Community Acquired Pneumonia, Complicated Skin and Soft Tissue Infection
Conditions
Keywords
Bacteria, Zinforo® (ceftaroline fosamil), CAP, cSSTi, Hospitalized, Infectious Disease, Antibiotic, Cephalosporin
Brief summary
MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting
Detailed description
The overall study aim is to provide real world evidence (RWE) on the characteristics, clinical management, treatment outcomes and healthcare resource use of adult patients aged 18 years and older admitted to the hospital for CAP or cSSTI who received Zinforo® in a usual care setting in Europe and Latin America on or before 31-May-2019.
Interventions
IV Solution
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age 18 years or older at admission date to the hospital; 2. Received four (4) or more consecutive IV doses of Zinforo® in usual care on or before 31-May-2019; and 3. Admitting diagnosis to the hospital was either CAP or cSSTI.
Exclusion criteria
1. Patients who were participating in an interventional clinical trial during the same hospital admission in which Zinforo® was administered; 2. Patients whose hospital medical records are missing documentation of the diagnostic criteria for either cSSTI or CAP; 3. Patients whose hospital medical records are missing details of dosing with Zinforo®; 4. Patients whose hospital medical records are missing information on the success/failure of Zinforo® treatment and the reason why treatment was discontinued; and 5. Patients whose hospital medical records are missing discharge date and status information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response | Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the Infectious Disease Society of America \[IDSA\] guidelines a temperature of less than or equal to (\<=) 37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of greater than or equal to (\>=) 90 millimeters of mercury (mmHg), oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area. |
| Time to Clinical Response | Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area. |
| Number of Participants Who Achieved Clinical Cure | Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Participants who achieved clinical cure were reported in this outcome measure. |
| Time to Clinical Cure | Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Time taken to achieve the clinical cure was reported in this outcome measure. |
| Number of Participants With Clinical Failure | Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to adverse event (AE); drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. |
| CAP: Number of Participants According to Reasons for Clinical Failure | Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study) | Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with CAP, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported. |
| cSSTI: Number of Participants According to Reasons for Clinical Failure | Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study) | Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with cSSTI, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported. |
| CAP Only: Time to Clinical Stability | Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study) | Clinical stability was defined according to the IDSA guidelines as temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent. The time to achieve clinical stability was reported in this outcome measure. |
| CAP Only: Time to Clinical Improvement | Baseline (before Day 1 of Zinforo treatment) till end of Zinforo treatment, up to maximum of 35 days [from the retrospective data evaluated in approximately 14 months of the study] | Clinical improvement was defined as improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none. The time to clinical improvement was reported in this outcome measure. |
| CAP: Number of Participants With Early Response Within 4 Days | Within 4 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study) | Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Participants with CAP who showed response within 4 days after treatment with Zinforo were reported in this outcome measure. |
| Number of Participants With Re-hospitalization Within 30 Days of Discharge | Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study] | The number of participants who were re-hospitalized within 30 days of discharge were reported in this outcome measure. |
| cSSTI: Number of Participants With Early Response Within 3 Days | Within 3 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study) | Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area. Participants with cSSTI who showed response within 3 days after treatment with Zinforo were reported in this outcome measure. |
| cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area | Baseline (before Day 1 of treatment) till end of treatment, up to maximum of 60 days [from the retrospective data evaluated in approximately 14 months of the study] | The response to treatment in cSSTI participants was measured as \>=20% reduction from baseline in infection area. |
| cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area | Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study) | The response to treatment in cSSTI participants was measured as cessation of spread of infection measured by total infection area. |
| cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width | Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study) | Time taken for the cessation of spread of infection as measured by length and width of the infected area was reported in this outcome measure. |
| Number of Participants According to Discharge Status | At discharge from hospital: any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Participants were categorized based on the discharge status in this outcome measure. |
| Number of Participants According to Vital Status Within 30 Days of Discharge | Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study] | The number of participants were classified according to the vital status in this outcome measure. |
| Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment | From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study] | MIC was defined as the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism. Participants were categorized as Yes, No or Unknown against being assessed for MIC. |
| Day of MIC Assessment Since Index Hospitalization | From Day 1 of Index hospitalization till MIC assessment, any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Day of MIC assessment since the index hospitalization was reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. |
| Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study] | Pathogens for bacterial pneumonia were identified by blood, respiratory (e.g., sputum, bronchoalveolar lavage), or pleural effusion cultures and pathogens for cSSTI were identified blood or skin/soft tissue/bone/wound cultures. Number of participants with MIC of antibacterial drugs for pathogens isolated from samples were reported in this outcome measure. |
| Number of Participants With Serious Adverse Events | Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; hospitalization/prolongation of hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. |
| Number of Participants With Medical Conditions Presented at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who had any medical conditions at the time of index hospitalization were reported in this outcome measure. Medical conditions that were considered included Human Immunodeficiency Virus (HIV) infection, alcohol abuse, cancer/malignancy, cerebrovascular disease, chronic dialysis within the past 30 days, chronic obstructive pulmonary disease, chronic renal disease, congestive heart failure, decompensated cirrhosis, diabetes mellitus, immunosuppressive disease, influenza, injection drug use, end stage liver disease, peripheral vascular disease, respiratory disease or any other relevant condition(s) or disease(s) that required chronic drug treatment. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. |
| Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization | 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who had hospitalization for any reason, 3 months before the index hospitalization were reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. |
| Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization | 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who had undergone surgical treatments, 3 months before to the index hospitalization were reported in this outcome measure. |
| Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study) | Number of participants according to therapies received in the 3 months prior to index hospitalization were reported in this outcome measure. One participant could receive more than one therapy. |
| Number of Participants With Radiographic Findings in Tests for CAP | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | Participants were categorized according to radiographic findings in the tests conducted for diagnosis of CAP infection in this outcome measure. One participant could have more than one radiographic finding. |
| CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | Participants were categorized according to triggering signs and symptoms at CAP diagnosis and recorded at index hospital admission were reported in this outcome measure. The observed signs and symptoms were dyspnea, tachypnea, or hypoxemia (oxygen \[O2\] saturation \< 90% on room air or partial pressure of oxygen (pO2) \< 60 mmHg), Fever (\>38 degree Celsius\[C\]oral; \> 38.5 degree C rectally or tympanically) or hypothermia (\< 35 degree C), White Blood Cell (WBC) count \> 10,000 cells/cubic millimeter(mm³) or \< 4,500 cells/mm³. One participant could have more than one signs or symptoms. |
| Number of Participants With Severe CAP | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | Number of participants diagnosed with severe CAP were reported in this outcome measure. |
| Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity | At index hospitalization admission(from the retrospective data evaluated in approximately 14 months of the study) | In this outcome measure participants were categorized according to type of assessment used to assess CAP severity. Pneumonia severity index (PSI)/PORT score was used to calculate the probability of morbidity and mortality among participants with CAP. The score was used to predict the need for hospitalization in people with pneumonia. CURB- 65 was used to measure the confusion, blood urea, respiratory rate, blood pressure for the participants aged greater than or equal to 65 years. Multiple criteria to assess the severity of CAP exist. In this study severity was first globally assessed asking if a (any) criterion for severity of CAP would apply. In subsequent questions the details on the exact methods of the severity assessment were then asked. This included the information about PORT score / PSI, CURB-65 and recurrency of CAP. |
| Time of CAP Diagnosis at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The time taken (in days) taken to diagnose CAP in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission. |
| Number of Participants With Recurrent CAP Infections at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants with recurrent CAP infections were reported in this outcome measure. |
| Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the various pathogens identified during CAP diagnosis in this outcome measure. |
| Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the type of investigations performed for the microbiological CAP diagnosis and were reported in this outcome measure. |
| CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | In this outcome measure number of participants who had H1N1 Influenza virus determined using PCR were reported. |
| CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization | 12 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants according to the status of influenza vaccination were reported in this outcome measure, as vaccinated: Yes, No and Unknown. |
| CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants according to the status of pneumococcal vaccination were reported in this outcome measure. |
| CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the biomarkers used for monitoring the state of CAP in this outcome measure. |
| cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants classified according to the types of lesions involved in the cSSTI infection were reported in this outcome measure. One participant could have more than one type of lesion. |
| cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the body area involved in cSSTI are reported in this outcome measure. One participant could have more than one type of body area involvement. |
| cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the extent of skin that was affected with the infection in this outcome measure. |
| cSSTI: Number of Participants According to Level of Infections at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the level of infections in this outcome measure. |
| cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the anatomical structures involved in the infections in this outcome measure. |
| Time of cSSTI Diagnosis at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The time taken (in days) taken to diagnose cSSTI in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission. |
| cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants that had recurrent cSSTI infections were reported in this outcome measure. |
| cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants with triggering signs and symptoms during the cSSTI diagnosis were reported in this outcome measure. One participant could have more than one triggering signs and symptoms. |
| Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the systemic signs observed Including temperature greater than (\>) 30 degree Celsius, White blood cell count \>10,000 cells per millimeter cube(/mm3) or \<4,500/mm3 or immature neutrophils \>10%, septic shock, organ dysfunction and none of the above mentioned were reported. One participant could have more than one systemic sign. |
| cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants classified according to the diagnostic tests conducted to diagnose cSSTI were reported in this outcome measure. One participant could have more than one type of diagnostic test. |
| cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study) | Pathogens identified by blood or skin/soft tissue/bone/wound cultures were recorded for participants with cSSTI. |
| Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to types of antibiotics that they received prior to Zinforo and reported in this outcome measure. |
| Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the lines of therapy in this outcome measure. |
| Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to various routes of administration for pre-Zinforo treatment and were reported in this outcome measure. |
| Duration of Pre-Zinforo Treatment During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Time From Symptom Onset to First Dose of Pre-Zinforo Treatment | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to types of Pre-Zinforo treatment and were reported in this outcome measure. One participant could have more than one type of pre-Zinforo treatment. |
| Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who had pre-Zinforo treatment modification were reported in this outcome measure. |
| Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants classified according to the reasons for pre-Zinforo treatment modification were reported in this outcome measure. One participant could have more than one reason for treatment modification. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. One participant could have more than one reason for treatment modification. |
| Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Treatment response was defined according to the following criteria: CAP participants who demonstrated clinical stability (defined according to the Infectious Diseases Society of America \[IDSA\] guidelines as temperature of ≤37.8 C°, heart rate of ≤100 beats/min, respiratory rate of ≤24 breaths/min, systolic blood pressure of ≥90mmHg, oxygen saturation of ≥90%, and confusion/disorientation recorded as absent) and clinical improvement{defined as improvement of at least 1 of 4 symptoms present at baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none}. cSSTI participants: ≥20% reduction from baseline infection area and cessation of spread measured by total infection area. The number of participants were classified according to treatment response to pre-Zinforo treatment and were reported in this outcome measure. |
| Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment | Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The time (days) taken for modification from initial dose of pre-Zinforo treatment were reported in this outcome measure. |
| Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization | Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants with insufficient response to pre-Zinforo treatment were reported in this outcome measure. |
| Duration of Zinforo Treatment During Index Hospitalization | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The duration of Zinforo treatment for CAP and cSSTI infections were reported in this outcome measure. |
| Time From Admission to First Dose of Zinforo During Index Hospitalization | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The time taken from admission to the administration of first dose of Zinforo was reported in this outcome measure. |
| Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The time taken for the symptom onset to the administration of first dose of Zinforo was reported in this outcome measure. |
| Number of Participants According to Types of Treatment for Zinforo | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants classified according to the types of treatment for Zinforo were reported in this outcome measure. Types included empiric, definitive/specific and unknown. Empiric was defined as therapy administered to participants prior to the results of blood culture and susceptibility tests. Definitive was defined as therapy administered after the test results were received. |
| Daily Dose of Zinforo | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Number of Infusions Administered Daily for Zinforo | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Number of Participants According to Locations of Zinforo Administration | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the locations where Zinforo was administered were reported in this outcome measure. One participant could have more than one location of Zinforo administration. |
| Number of Participants Administered Zinforo as Monotherapy or Combination Therapy | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to Zinforo administration as monotherapy or combination therapy were reported in this outcome measure. |
| Number of Participants Receiving Concomitant Therapies Along With Zinforo | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Number of participants who received concomitant therapies along with Zinforo were reported in this outcome measure. |
| Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to types of antibiotics received for index infection (CAP and cSSTI) after the Zinforo treatment were reported in this outcome measure. One participant could receive more than one type of antibiotic. |
| Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the lines of therapy for post-Zinforo treatment were reported in this outcome measure. |
| Number of Participants According to Route of Administration for Post-Zinforo Treatment | CAP (up to maximum of 102 days), cSSTI (up to maximum of 162 days) | The number of participants were classified according to routes of administration for post-Zinforo treatment were reported in this outcome measure. |
| Duration From Zinforo Discontinuation to Initiation of New Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The duration in days from Zinforo treatment discontinuation to initiation of new treatment were reported in this outcome measure. |
| Number of Doses Administered for Post Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the reasons for switching to post-Zinforo treatment were reported in this outcome measure. One participant could have more than one reason for switch. |
| Number of Participants Based on Treatment Response to Post-Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical response in CAP:participants demonstrating clinical stability(i.e.,according to IDSA guidelines:temperature of\<=37.8 degree Celsius,heart rate of \<=100 beats per minute,respiratory rate of \<=24 breaths per minute,systolic blood pressure of \>=90 mmHg,oxygen saturation of \>=90%,confusion/disorientation recorded as absent),clinical improvement(i.e.,improvement of at least 1 of 4 symptoms present at Baseline(i.e.,cough,dyspnea,pleuritic chest pain,sputum production)with worsening of none).Clinical response in cSSTI participants:\>=20% reduction from baseline infection area,cessation of spread measured by total infection area.Clinical failure for both CAP and cSSTI:any of the following:treatment modification due to AE;drug-drug interaction;insufficient response(followed by switch);death due to index infection;death due to other cause;relapse or recurrence. Number of participants classified according to treatment responses to post-Zinforo treatment reported in this outcome measure. |
| Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to the locations in which post-Zinforo treatment was administered. One participant could have more than one location of administration. |
| Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area. |
| Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. The number of participants were classified according to the reasons for clinical failure post-Zinforo treatment were reported in this outcome measure. |
| Duration of Index Hospitalization | Day 1 of admission of index hospitalization to discharge from hospital (from the retrospective data evaluated in approximately 14 months of the study) | Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. |
| Duration in Intensive Care Unit | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo | Post initiation of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who received renal replacement therapy after initiating treatment with Zinforo were reported in this outcome measure. |
| Number of Participants According to Treatments Received During Index Hospitalization | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to treatments received during index hospitalization were reported in this outcome measure. |
| Number of Participants Who Received Home-Based Care Through a Healthcare Agency | Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who received home-based care through a healthcare agency were reported in this outcome measure. |
| Number of Participants With Re-hospitalizations | Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who had re-hospitalizations were reported in this outcome measure. |
| Duration of Re-hospitalizations | Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study) | In this outcome measure, data is recorded for duration (in days) of re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization. |
| Number of Participants According to Reasons for Re-hozpitalization | Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants were classified according to reasons for re-hospitalizations were reported in this outcome measure. Re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization. |
| Number of Participants With Development of Sepsis During Index Hospitalization | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who developed sepsis during index hospitalization were reported in this outcome measure. |
| Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The qSOFA (also known as quickSOFA) was a bedside prompt that identified participants with suspected infection who are at greater risk for a poor outcome outside the intensive care unit (ICU). It used three criteria, assigning one point for low blood pressure Systolic blood pressure less than or equal to 100 millimeters of mercury (SBP\<=100 mmHg), high respiratory rate greater than or equal to (\>=) 22 breaths per min, or altered mentation (Glasgow coma scale\<15). |
| Number of Participants Requiring Isolation | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who required isolation were reported in this outcome measure. |
| Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement | During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The number of participants who suffered from acute renal failure and necessitated renal replacement were reported in this outcome measure. |
| Total Number of Doses of Zinforo Administered | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo | Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Total Dose of Other Antibiotics Administered Post Zinforo Treatment | Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | — |
| Cost of Hospitalization | Day 1 of index hospitalization till discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study) | The cost of hospitalization of standard level hospitals was calculated as total hospital cost= total number of bed days \* per diem rate standard hospital general ward and the cost of hospitalization of advanced level hospitals was calculated as total number of bed days \* per diem rate advanced hospital. |
Countries
Brazil, Colombia, France, Greece, Italy, Russia, Spain
Participant flow
Recruitment details
Participants hospitalized for Community Acquired Pneumonia (CAP) or Complicated Soft Skin Tissue Infections (cSSTI) and treated with four or more consecutive intravenous (IV) doses of Zinforo (ceftaroline fosamil) in a usual care setting on or before 31-May-2019, were included. Data was collected retrospectively from hospital records and evaluated over approximately 14 months of this study.
Participants by arm
| Arm | Count |
|---|---|
| Participants With CAP Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days. | 185 |
| Participants With cSSTI Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days. | 132 |
| Total | 317 |
Baseline characteristics
| Characteristic | Participants With CAP | Participants With cSSTI | Total |
|---|---|---|---|
| Age, Customized 18 to less than or equal to 65 years | 90 Participants | 83 Participants | 173 Participants |
| Age, Customized Greater than 65 years | 95 Participants | 49 Participants | 144 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 76 Participants | 55 Participants | 131 Participants |
| Sex: Female, Male Male | 109 Participants | 77 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 31 / 185 | 15 / 132 |
| other Total, other adverse events | 0 / 185 | 0 / 132 |
| serious Total, serious adverse events | 0 / 185 | 2 / 132 |
Outcome results
CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization
The number of participants according to the status of influenza vaccination were reported in this outcome measure, as vaccinated: Yes, No and Unknown.
Time frame: 12 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization | Yes | 32 Participants |
| Participants With CAP | CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization | No | 64 Participants |
| Participants With CAP | CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization | Unknown | 89 Participants |
CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization
The number of participants according to the status of pneumococcal vaccination were reported in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization | Yes | 18 Participants |
| Participants With CAP | CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization | No | 76 Participants |
| Participants With CAP | CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization | Unknown | 91 Participants |
CAP: Number of Participants According to Reasons for Clinical Failure
Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with CAP, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | CAP: Number of Participants According to Reasons for Clinical Failure | Death due to index infection | 7 Participants |
| Participants With CAP | CAP: Number of Participants According to Reasons for Clinical Failure | Insufficient response | 21 Participants |
| Participants With CAP | CAP: Number of Participants According to Reasons for Clinical Failure | Death due to other | 2 Participants |
| Participants With CAP | CAP: Number of Participants According to Reasons for Clinical Failure | Relapse or recurrence | 2 Participants |
| Participants With CAP | CAP: Number of Participants According to Reasons for Clinical Failure | Unknown | 2 Participants |
CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization
The number of participants were classified according to the biomarkers used for monitoring the state of CAP in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization | C-reactive protein (CRP) | 182 Participants |
| Participants With CAP | CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization | Procalcitonin | 73 Participants |
| Participants With CAP | CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization | Other biomarker | 8 Participants |
| Participants With CAP | CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization | None of the above | 2 Participants |
CAP: Number of Participants With Early Response Within 4 Days
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Participants with CAP who showed response within 4 days after treatment with Zinforo were reported in this outcome measure.
Time frame: Within 4 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | CAP: Number of Participants With Early Response Within 4 Days | 79 Participants |
CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization
In this outcome measure number of participants who had H1N1 Influenza virus determined using PCR were reported.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization | 71 Participants |
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Participants were categorized according to triggering signs and symptoms at CAP diagnosis and recorded at index hospital admission were reported in this outcome measure. The observed signs and symptoms were dyspnea, tachypnea, or hypoxemia (oxygen \[O2\] saturation \< 90% on room air or partial pressure of oxygen (pO2) \< 60 mmHg), Fever (\>38 degree Celsius\[C\]oral; \> 38.5 degree C rectally or tympanically) or hypothermia (\< 35 degree C), White Blood Cell (WBC) count \> 10,000 cells/cubic millimeter(mm³) or \< 4,500 cells/mm³. One participant could have more than one signs or symptoms.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | New or increased cough | 129 Participants |
| Participants With CAP | CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Purulent sputum or change in sputum character | 80 Participants |
| Participants With CAP | CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Auscultatory findings consistent with pneumonia | 138 Participants |
| Participants With CAP | CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Dyspnea, tachypnea, or hypoxemia (O2 saturation < 90% on room air or pO2 < 60 mmHg) | 148 Participants |
| Participants With CAP | CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Fever (>38 degree C oral; > 38.5 degree C rectally or tympanically) or hypothermia (< 35 degree C) | 127 Participants |
| Participants With CAP | CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | WBC count > 10,000 cells/mm³ or < 4,500 cells/mm³ | 122 Participants |
CAP Only: Time to Clinical Improvement
Clinical improvement was defined as improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none. The time to clinical improvement was reported in this outcome measure.
Time frame: Baseline (before Day 1 of Zinforo treatment) till end of Zinforo treatment, up to maximum of 35 days [from the retrospective data evaluated in approximately 14 months of the study]
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | CAP Only: Time to Clinical Improvement | 3 Days |
CAP Only: Time to Clinical Stability
Clinical stability was defined according to the IDSA guidelines as temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent. The time to achieve clinical stability was reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | CAP Only: Time to Clinical Stability | 3 Days |
Cost of Hospitalization
The cost of hospitalization of standard level hospitals was calculated as total hospital cost= total number of bed days \* per diem rate standard hospital general ward and the cost of hospitalization of advanced level hospitals was calculated as total number of bed days \* per diem rate advanced hospital.
Time frame: Day 1 of index hospitalization till discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With CAP | Cost of Hospitalization | Standard hospital cost | 9204.62 US dollars | Standard Deviation 12895.23 |
| Participants With CAP | Cost of Hospitalization | Advanced level cost | 25408.01 US dollars | Standard Deviation 31704.58 |
| Participants With cSSTI | Cost of Hospitalization | Standard hospital cost | 5196.2 US dollars | Standard Deviation 9070.35 |
| Participants With cSSTI | Cost of Hospitalization | Advanced level cost | 20257.18 US dollars | Standard Deviation 36809.71 |
cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization
The number of participants were classified according to the extent of skin that was affected with the infection in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization | Less than (<) 5 centimeter square (cm^2) | 12 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization | 5-10 cm^2 | 31 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization | 10-50 cm^2 | 34 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization | Greater than (>) 50 cm^2 | 8 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization | Unknown | 47 Participants |
cSSTI: Number of Participants According to Level of Infections at Index Hospitalization
The number of participants were classified according to the level of infections in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Level of Infections at Index Hospitalization | Superficial | 51 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Level of Infections at Index Hospitalization | Deep incisional | 51 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Level of Infections at Index Hospitalization | Organ or space infection | 20 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Level of Infections at Index Hospitalization | Unknown | 10 Participants |
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Pathogens identified by blood or skin/soft tissue/bone/wound cultures were recorded for participants with cSSTI.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Methicillin resistance Staphylococcus aureus | 24 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Methicillin susceptible S. aureus (MSSA) | 23 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Staphylococcus coagulase negative | 8 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Streptococcus pneumonia | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Streptococcus pyogenes | 4 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Streptococcus agalactiae | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Enterococcus faecalis | 2 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Gram-negative bacilli | 12 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Non-fermenting enterobacteria | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Other strict anaerobic bacteria | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Other microorganism | 8 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Mixed flora | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | Unknown | 24 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization | None of the above | 40 Participants |
cSSTI: Number of Participants According to Reasons for Clinical Failure
Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with cSSTI, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Reasons for Clinical Failure | Treatment modification due to AE | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Reasons for Clinical Failure | Insufficient response | 10 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Reasons for Clinical Failure | Relapse or recurrence | 3 Participants |
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
The number of participants were classified according to the anatomical structures involved in the infections in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | Epithelium | 61 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | Epidermis | 92 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | Dermis | 88 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | Subcutaneous fat | 61 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | Fascia | 23 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | Muscle | 25 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization | Unknown | 23 Participants |
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
The number of participants were classified according to the body area involved in cSSTI are reported in this outcome measure. One participant could have more than one type of body area involvement.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Head | 13 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Hand | 3 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Upper extremities | 14 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Lower extremities | 74 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Thorax | 19 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Abdomen | 14 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Genitalia | 9 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization | Unknown | 1 Participants |
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
The number of participants classified according to the diagnostic tests conducted to diagnose cSSTI were reported in this outcome measure. One participant could have more than one type of diagnostic test.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Blood cultures | 85 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Superficial swab and culture | 40 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Needle aspiration | 14 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Skin biopsy | 7 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Surgical sample | 22 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | X-ray | 31 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Ultrasound | 58 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Computed Tomography (CT)/ Magnetic Resonance Imaging (MRI) | 35 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization | Unknown/not performed | 6 Participants |
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
The number of participants classified according to the types of lesions involved in the cSSTI infection were reported in this outcome measure. One participant could have more than one type of lesion.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Abscess | 45 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Cellulitis/fasciitis | 82 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Post-traumatic wound | 9 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Post-surgical wound | 26 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Decubitus ulcer | 5 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Diabetic leg ulcer | 5 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Peripheral vascular disease ulcer | 3 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Bite | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | Unknown | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization | None of the above | 2 Participants |
cSSTI: Number of Participants With Early Response Within 3 Days
Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area. Participants with cSSTI who showed response within 3 days after treatment with Zinforo were reported in this outcome measure.
Time frame: Within 3 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | cSSTI: Number of Participants With Early Response Within 3 Days | 20 Participants |
cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization
The number of participants that had recurrent cSSTI infections were reported in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization | 33 Participants |
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
The number of participants with triggering signs and symptoms during the cSSTI diagnosis were reported in this outcome measure. One participant could have more than one triggering signs and symptoms.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Purulent or seropurulent drainage/discharge | 65 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Bullae | 5 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Erythema | 106 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Fluctuance | 30 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Heat/localized warmth | 90 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Pain/tenderness to palpitation | 100 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Swelling/induration | 78 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Skin necrosis | 9 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Anesthesia | 1 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Crackling | 3 Participants |
| Participants With CAP | cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization | Induration beyond the erythematous area | 17 Participants |
cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width
Time taken for the cessation of spread of infection as measured by length and width of the infected area was reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width | 2 Days |
cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area
The response to treatment in cSSTI participants was measured as cessation of spread of infection measured by total infection area.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area | 2 Days |
cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area
The response to treatment in cSSTI participants was measured as \>=20% reduction from baseline in infection area.
Time frame: Baseline (before Day 1 of treatment) till end of treatment, up to maximum of 60 days [from the retrospective data evaluated in approximately 14 months of the study]
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area | 3 Days |
Daily Dose of Zinforo
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With CAP | Daily Dose of Zinforo | 1183.24 Milligrams | Standard Deviation 412.69 |
| Participants With cSSTI | Daily Dose of Zinforo | 1239.39 Milligrams | Standard Deviation 402.43 |
Day of MIC Assessment Since Index Hospitalization
Day of MIC assessment since the index hospitalization was reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Time frame: From Day 1 of Index hospitalization till MIC assessment, any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Day of MIC Assessment Since Index Hospitalization | 1 Days |
| Participants With cSSTI | Day of MIC Assessment Since Index Hospitalization | 4 Days |
Duration From Zinforo Discontinuation to Initiation of New Treatment
The duration in days from Zinforo treatment discontinuation to initiation of new treatment were reported in this outcome measure.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Duration From Zinforo Discontinuation to Initiation of New Treatment | 1 Days |
| Participants With cSSTI | Duration From Zinforo Discontinuation to Initiation of New Treatment | 1 Days |
Duration in Intensive Care Unit
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Duration in Intensive Care Unit | 0 Days |
| Participants With cSSTI | Duration in Intensive Care Unit | 0 Days |
Duration of Index Hospitalization
Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Time frame: Day 1 of admission of index hospitalization to discharge from hospital (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Duration of Index Hospitalization | 12 Days |
| Participants With cSSTI | Duration of Index Hospitalization | 11 Days |
Duration of Pre-Zinforo Treatment During Index Hospitalization
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Duration of Pre-Zinforo Treatment During Index Hospitalization | 6 Days |
| Participants With cSSTI | Duration of Pre-Zinforo Treatment During Index Hospitalization | 8 Days |
Duration of Re-hospitalizations
In this outcome measure, data is recorded for duration (in days) of re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization.
Time frame: Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Duration of Re-hospitalizations | 10.5 Days |
| Participants With cSSTI | Duration of Re-hospitalizations | 9 Days |
Duration of Zinforo Treatment During Index Hospitalization
The duration of Zinforo treatment for CAP and cSSTI infections were reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Duration of Zinforo Treatment During Index Hospitalization | 7 Days |
| Participants With cSSTI | Duration of Zinforo Treatment During Index Hospitalization | 8 Days |
Number of Doses Administered for Post Zinforo Treatment
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With CAP | Number of Doses Administered for Post Zinforo Treatment | 11.05 Doses | Standard Deviation 14.82 |
| Participants With cSSTI | Number of Doses Administered for Post Zinforo Treatment | 16.38 Doses | Standard Deviation 21.81 |
Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With CAP | Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization | 2.02 Doses | Standard Deviation 0.93 |
| Participants With cSSTI | Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization | 2.18 Doses | Standard Deviation 1.54 |
Number of Infusions Administered Daily for Zinforo
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With CAP | Number of Infusions Administered Daily for Zinforo | 2.28 Infusions | Standard Deviation 0.47 |
| Participants With cSSTI | Number of Infusions Administered Daily for Zinforo | 2.27 Infusions | Standard Deviation 0.46 |
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
The number of participants were classified according to the locations in which post-Zinforo treatment was administered. One participant could have more than one location of administration.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | ICU | 70 Participants |
| Participants With CAP | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | General ward | 86 Participants |
| Participants With CAP | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | At home | 64 Participants |
| Participants With CAP | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | Out-patient setting | 9 Participants |
| Participants With CAP | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | Medical clinic | 6 Participants |
| Participants With CAP | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | Other | 0 Participants |
| Participants With cSSTI | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | Medical clinic | 5 Participants |
| Participants With cSSTI | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | ICU | 1 Participants |
| Participants With cSSTI | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | Out-patient setting | 16 Participants |
| Participants With cSSTI | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | General ward | 42 Participants |
| Participants With cSSTI | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | Other | 1 Participants |
| Participants With cSSTI | Number of Participant According to Type of Location for Post-Zinforo Treatment Administration | At home | 70 Participants |
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
The number of participants were classified according to types of antibiotics that they received prior to Zinforo and reported in this outcome measure.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Carbapenem | 12 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Betalactam/Combination | 36 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Cephalosporins | 19 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Quinolone | 50 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Betalactam | 17 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Sulfonamide | 37 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Glycopeptide | 4 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Clindamycin | 1 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Ceftriaxone | 45 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Other antibiotic agent | 15 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Macrolide | 13 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Unknown | 17 Participants |
| Participants With CAP | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Aminoglycoside | 5 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Unknown | 31 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Aminoglycoside | 6 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Betalactam | 20 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Carbapenem | 4 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Ceftriaxone | 10 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Cephalosporins | 16 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Glycopeptide | 18 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Macrolide | 23 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Betalactam/Combination | 6 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Quinolone | 21 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Sulfonamide | 10 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Clindamycin | 4 Participants |
| Participants With cSSTI | Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization | Other antibiotic agent | 8 Participants |
Number of Participants According to Discharge Status
Participants were categorized based on the discharge status in this outcome measure.
Time frame: At discharge from hospital: any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Discharge Status | Died in the hospital | 18 Participants |
| Participants With CAP | Number of Participants According to Discharge Status | Discharged to a nursing home or extended care facility | 28 Participants |
| Participants With CAP | Number of Participants According to Discharge Status | Discharged to independent living (with or without support) | 138 Participants |
| Participants With CAP | Number of Participants According to Discharge Status | Other | 1 Participants |
| Participants With cSSTI | Number of Participants According to Discharge Status | Other | 2 Participants |
| Participants With cSSTI | Number of Participants According to Discharge Status | Died in the hospital | 6 Participants |
| Participants With cSSTI | Number of Participants According to Discharge Status | Discharged to independent living (with or without support) | 101 Participants |
| Participants With cSSTI | Number of Participants According to Discharge Status | Discharged to a nursing home or extended care facility | 23 Participants |
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
The number of participants were classified according to the lines of therapy in this outcome measure.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | First | 134 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Second | 85 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Third | 40 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Fourth | 20 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Fifth | 5 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Sixth | 2 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Seventh | 1 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Eighth | 1 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Nineth | 0 Participants |
| Participants With CAP | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Tenth | 0 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Eighth | 3 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | First | 87 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Sixth | 3 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Second | 58 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Tenth | 1 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Third | 24 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Seventh | 3 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Fourth | 13 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Nineth | 1 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization | Fifth | 5 Participants |
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
The number of participants were classified according to the lines of therapy for post-Zinforo treatment were reported in this outcome measure.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | First | 1 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Second | 45 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Third | 40 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Fourth | 51 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Fifth | 26 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Sixth | 25 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Seventh | 5 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Eighth | 8 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Nineth | 3 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Tenth | 0 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Eleventh | 0 Participants |
| Participants With CAP | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Twelfth | 0 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Eleventh | 1 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | First | 2 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Seventh | 5 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Second | 46 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Tenth | 1 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Third | 20 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Eighth | 2 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Fourth | 21 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Twelfth | 1 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Fifth | 11 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Nineth | 4 Participants |
| Participants With cSSTI | Number of Participants According to Lines of Therapy for Post-Zinforo Treatment | Sixth | 5 Participants |
Number of Participants According to Locations of Zinforo Administration
The number of participants were classified according to the locations where Zinforo was administered were reported in this outcome measure. One participant could have more than one location of Zinforo administration.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Locations of Zinforo Administration | General ward | 115 Participants |
| Participants With CAP | Number of Participants According to Locations of Zinforo Administration | Medical clinic | 30 Participants |
| Participants With CAP | Number of Participants According to Locations of Zinforo Administration | At home | 1 Participants |
| Participants With CAP | Number of Participants According to Locations of Zinforo Administration | Out-patient setting | 0 Participants |
| Participants With CAP | Number of Participants According to Locations of Zinforo Administration | Intensive Care Unit (ICU) | 66 Participants |
| Participants With cSSTI | Number of Participants According to Locations of Zinforo Administration | Out-patient setting | 2 Participants |
| Participants With cSSTI | Number of Participants According to Locations of Zinforo Administration | Intensive Care Unit (ICU) | 11 Participants |
| Participants With cSSTI | Number of Participants According to Locations of Zinforo Administration | General ward | 114 Participants |
| Participants With cSSTI | Number of Participants According to Locations of Zinforo Administration | At home | 14 Participants |
| Participants With cSSTI | Number of Participants According to Locations of Zinforo Administration | Medical clinic | 14 Participants |
Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens
Pathogens for bacterial pneumonia were identified by blood, respiratory (e.g., sputum, bronchoalveolar lavage), or pleural effusion cultures and pathogens for cSSTI were identified blood or skin/soft tissue/bone/wound cultures. Number of participants with MIC of antibacterial drugs for pathogens isolated from samples were reported in this outcome measure.
Time frame: From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of ceftaroline for all isolated pathogens | 5 Participants |
| Participants With CAP | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of oxacillin, vancomycin, linezolid, and daptomycin for Staphylococcus aureus | 12 Participants |
| Participants With CAP | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of ceftriaxone for Methicillin-Susceptible Staphylococcus aureus (MSSA) | 3 Participants |
| Participants With CAP | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of penicillin and ceftriaxone for Streptococcus pneumonia | 10 Participants |
| Participants With cSSTI | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of penicillin and ceftriaxone for Streptococcus pneumonia | 0 Participants |
| Participants With cSSTI | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of ceftaroline for all isolated pathogens | 7 Participants |
| Participants With cSSTI | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of ceftriaxone for Methicillin-Susceptible Staphylococcus aureus (MSSA) | 6 Participants |
| Participants With cSSTI | Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens | MIC of oxacillin, vancomycin, linezolid, and daptomycin for Staphylococcus aureus | 20 Participants |
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
The number of participants were classified according to the various pathogens identified during CAP diagnosis in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Streptococcus pneumonia | 44 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Escherichia coli | 2 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Hemophilus influenza | 3 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | H. Parainfluenza | 1 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Legionella spp. | 2 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Staphylococcus aureus | 4 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Methicillin resistance Staphylococcus aureus | 14 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Methicillin susceptible Staphylococcus. aureus | 15 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Klebsiella pneumonia | 3 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Other enterobacteria | 2 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Pseudomonas aeruginosa | 1 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Other microorganism | 26 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | Unknown | 15 Participants |
| Participants With CAP | Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization | None of the above | 72 Participants |
Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment
MIC was defined as the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism. Participants were categorized as Yes, No or Unknown against being assessed for MIC.
Time frame: From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment | Yes | 23 Participants |
| Participants With CAP | Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment | No | 161 Participants |
| Participants With CAP | Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment | Unknown | 1 Participants |
| Participants With cSSTI | Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment | Yes | 28 Participants |
| Participants With cSSTI | Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment | No | 94 Participants |
| Participants With cSSTI | Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment | Unknown | 10 Participants |
Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment
Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. The number of participants were classified according to the reasons for clinical failure post-Zinforo treatment were reported in this outcome measure.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Insufficient response | 14 Participants |
| Participants With CAP | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Death due to infection | 6 Participants |
| Participants With CAP | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Relapse/reoccurrence | 1 Participants |
| Participants With CAP | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Death due to other | 3 Participants |
| Participants With CAP | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Treatment modification due to adverse event | 2 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Death due to other | 3 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Treatment modification due to adverse event | 0 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Insufficient response | 1 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Relapse/reoccurrence | 0 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment | Death due to infection | 0 Participants |
Number of Participants According to Reasons for Pre-Zinforo Treatment Modification
The number of participants classified according to the reasons for pre-Zinforo treatment modification were reported in this outcome measure. One participant could have more than one reason for treatment modification. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. One participant could have more than one reason for treatment modification.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Insufficient response | 58 Participants |
| Participants With CAP | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Streamlining | 29 Participants |
| Participants With CAP | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Possible interaction with other drug | 1 Participants |
| Participants With CAP | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Other | 14 Participants |
| Participants With CAP | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Adverse event | 5 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Other | 16 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Adverse event | 3 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Insufficient response | 42 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Possible interaction with other drug | 1 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Pre-Zinforo Treatment Modification | Streamlining | 9 Participants |
Number of Participants According to Reasons for Re-hozpitalization
The number of participants were classified according to reasons for re-hospitalizations were reported in this outcome measure. Re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization.
Time frame: Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Reasons for Re-hozpitalization | For index infection | 7 Participants |
| Participants With CAP | Number of Participants According to Reasons for Re-hozpitalization | For other reason | 13 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Re-hozpitalization | For index infection | 3 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Re-hozpitalization | For other reason | 10 Participants |
Number of Participants According to Reasons for Switching to Post-Zinforo Treatment
The number of participants were classified according to the reasons for switching to post-Zinforo treatment were reported in this outcome measure. One participant could have more than one reason for switch.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Side effect of previous treatment | 1 Participants |
| Participants With CAP | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Other | 124 Participants |
| Participants With CAP | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Results of susceptibility test/pathogen identification | 26 Participants |
| Participants With CAP | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Unknown | 14 Participants |
| Participants With CAP | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Lack of efficacy of previous treatment | 39 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Unknown | 6 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Lack of efficacy of previous treatment | 9 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Side effect of previous treatment | 9 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Results of susceptibility test/pathogen identification | 14 Participants |
| Participants With cSSTI | Number of Participants According to Reasons for Switching to Post-Zinforo Treatment | Other | 81 Participants |
Number of Participants According to Route of Administration for Post-Zinforo Treatment
The number of participants were classified according to routes of administration for post-Zinforo treatment were reported in this outcome measure.
Time frame: CAP (up to maximum of 102 days), cSSTI (up to maximum of 162 days)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Route of Administration for Post-Zinforo Treatment | Oral | 92 Participants |
| Participants With CAP | Number of Participants According to Route of Administration for Post-Zinforo Treatment | Intra-venous | 112 Participants |
| Participants With cSSTI | Number of Participants According to Route of Administration for Post-Zinforo Treatment | Oral | 81 Participants |
| Participants With cSSTI | Number of Participants According to Route of Administration for Post-Zinforo Treatment | Intra-venous | 38 Participants |
Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization
The number of participants were classified according to various routes of administration for pre-Zinforo treatment and were reported in this outcome measure.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Intra-venous | 111 Participants |
| Participants With CAP | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Subcutaneous | 0 Participants |
| Participants With CAP | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Intra-muscular | 7 Participants |
| Participants With CAP | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Unknown | 4 Participants |
| Participants With CAP | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Oral | 44 Participants |
| Participants With cSSTI | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Unknown | 3 Participants |
| Participants With cSSTI | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Oral | 31 Participants |
| Participants With cSSTI | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Intra-venous | 73 Participants |
| Participants With cSSTI | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Intra-muscular | 0 Participants |
| Participants With cSSTI | Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization | Subcutaneous | 1 Participants |
Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization
The number of participants were classified according to the systemic signs observed Including temperature greater than (\>) 30 degree Celsius, White blood cell count \>10,000 cells per millimeter cube(/mm3) or \<4,500/mm3 or immature neutrophils \>10%, septic shock, organ dysfunction and none of the above mentioned were reported. One participant could have more than one systemic sign.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization | Temperature > 38 degree Celsius | 77 Participants |
| Participants With CAP | Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization | White blood cell count | 108 Participants |
| Participants With CAP | Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization | Septic shock | 4 Participants |
| Participants With CAP | Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization | Organ dysfunction | 13 Participants |
| Participants With CAP | Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization | None of the above | 1 Participants |
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
Number of participants according to therapies received in the 3 months prior to index hospitalization were reported in this outcome measure. One participant could receive more than one therapy.
Time frame: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Anticoagulants | 38 Participants |
| Participants With CAP | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Home infusion therapy | 3 Participants |
| Participants With CAP | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Immunosuppressors/ immunomodulators | 21 Participants |
| Participants With CAP | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Home wound care provided by a medical professional | 6 Participants |
| Participants With CAP | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Non-steroid anti-inflammatory agents (NSAIs) | 13 Participants |
| Participants With CAP | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | None | 103 Participants |
| Participants With CAP | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Antimicrobial (e.g. antibiotics, antivirals) | 47 Participants |
| Participants With cSSTI | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | None | 39 Participants |
| Participants With cSSTI | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Antimicrobial (e.g. antibiotics, antivirals) | 56 Participants |
| Participants With cSSTI | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Immunosuppressors/ immunomodulators | 19 Participants |
| Participants With cSSTI | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Anticoagulants | 45 Participants |
| Participants With cSSTI | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Non-steroid anti-inflammatory agents (NSAIs) | 25 Participants |
| Participants With cSSTI | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Home infusion therapy | 2 Participants |
| Participants With cSSTI | Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization | Home wound care provided by a medical professional | 5 Participants |
Number of Participants According to Treatments Received During Index Hospitalization
The number of participants were classified according to treatments received during index hospitalization were reported in this outcome measure.
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support | 44 Participants |
| Participants With CAP | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support: Vasopressors | 44 Participants |
| Participants With CAP | Number of Participants According to Treatments Received During Index Hospitalization | Surgery unrelated to the infection | 1 Participants |
| Participants With CAP | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support: Invasive procedures | 2 Participants |
| Participants With CAP | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support: Fluid resuscitation | 32 Participants |
| Participants With CAP | Number of Participants According to Treatments Received During Index Hospitalization | None of the above | 139 Participants |
| Participants With CAP | Number of Participants According to Treatments Received During Index Hospitalization | Surgery related to the infection | 5 Participants |
| Participants With cSSTI | Number of Participants According to Treatments Received During Index Hospitalization | None of the above | 90 Participants |
| Participants With cSSTI | Number of Participants According to Treatments Received During Index Hospitalization | Surgery related to the infection | 37 Participants |
| Participants With cSSTI | Number of Participants According to Treatments Received During Index Hospitalization | Surgery unrelated to the infection | 0 Participants |
| Participants With cSSTI | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support | 12 Participants |
| Participants With cSSTI | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support: Fluid resuscitation | 7 Participants |
| Participants With cSSTI | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support: Vasopressors | 10 Participants |
| Participants With cSSTI | Number of Participants According to Treatments Received During Index Hospitalization | Blood pressure support: Invasive procedures | 0 Participants |
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
The number of participants were classified according to types of antibiotics received for index infection (CAP and cSSTI) after the Zinforo treatment were reported in this outcome measure. One participant could receive more than one type of antibiotic.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Carbapenem | 8 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Quinolone | 45 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Glycopeptide | 7 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Sulfonamide | 12 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Betalactam | 13 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Clindamycin | 32 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Macrolide | 12 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Other antibiotic agent | 12 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Ceftriaxone | 18 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Linezolid | 0 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Betalactam/Combination | 27 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Unknown | 9 Participants |
| Participants With CAP | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Aminoglycoside | 9 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Unknown | 0 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Aminoglycoside | 3 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Betalactam | 4 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Carbapenem | 5 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Ceftriaxone | 15 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Glycopeptide | 5 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Macrolide | 2 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Betalactam/Combination | 12 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Quinolone | 28 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Sulfonamide | 2 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Clindamycin | 21 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Other antibiotic agent | 20 Participants |
| Participants With cSSTI | Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment | Linezolid | 2 Participants |
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
The number of participants were classified according to the type of investigations performed for the microbiological CAP diagnosis and were reported in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Analysis population included all eligible participants whose data were retrieved from hospital medical records and assessed. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | Sputum examination | 33 Participants |
| Participants With CAP | Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | Blood culture | 39 Participants |
| Participants With CAP | Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | Bronchoalveolar lavage or bronchial brush examination | 10 Participants |
| Participants With CAP | Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | Pleural fluid sample examination | 4 Participants |
| Participants With CAP | Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | Legionella antigen test in urine | 5 Participants |
| Participants With CAP | Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | Pneumococcal antigen test in urine | 30 Participants |
| Participants With CAP | Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization | Other | 17 Participants |
Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity
In this outcome measure participants were categorized according to type of assessment used to assess CAP severity. Pneumonia severity index (PSI)/PORT score was used to calculate the probability of morbidity and mortality among participants with CAP. The score was used to predict the need for hospitalization in people with pneumonia. CURB- 65 was used to measure the confusion, blood urea, respiratory rate, blood pressure for the participants aged greater than or equal to 65 years. Multiple criteria to assess the severity of CAP exist. In this study severity was first globally assessed asking if a (any) criterion for severity of CAP would apply. In subsequent questions the details on the exact methods of the severity assessment were then asked. This included the information about PORT score / PSI, CURB-65 and recurrency of CAP.
Time frame: At index hospitalization admission(from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity | PORT Score / Pneumonia Severity Index | 18 Participants |
| Participants With CAP | Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity | CURB-65 | 41 Participants |
| Participants With CAP | Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity | Other | 15 Participants |
| Participants With CAP | Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity | None | 71 Participants |
| Participants With CAP | Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity | Unknown | 40 Participants |
Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization
The number of participants were classified according to types of Pre-Zinforo treatment and were reported in this outcome measure. One participant could have more than one type of pre-Zinforo treatment.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization | Empiric | 129 Participants |
| Participants With CAP | Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization | Definitive/Specific | 13 Participants |
| Participants With CAP | Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization | Unknown | 6 Participants |
| Participants With cSSTI | Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization | Empiric | 74 Participants |
| Participants With cSSTI | Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization | Definitive/Specific | 19 Participants |
| Participants With cSSTI | Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization | Unknown | 10 Participants |
Number of Participants According to Types of Treatment for Zinforo
The number of participants classified according to the types of treatment for Zinforo were reported in this outcome measure. Types included empiric, definitive/specific and unknown. Empiric was defined as therapy administered to participants prior to the results of blood culture and susceptibility tests. Definitive was defined as therapy administered after the test results were received.
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Types of Treatment for Zinforo | Empiric | 138 Participants |
| Participants With CAP | Number of Participants According to Types of Treatment for Zinforo | Definitive/Specific | 41 Participants |
| Participants With CAP | Number of Participants According to Types of Treatment for Zinforo | Unknown | 6 Participants |
| Participants With cSSTI | Number of Participants According to Types of Treatment for Zinforo | Empiric | 84 Participants |
| Participants With cSSTI | Number of Participants According to Types of Treatment for Zinforo | Definitive/Specific | 43 Participants |
| Participants With cSSTI | Number of Participants According to Types of Treatment for Zinforo | Unknown | 5 Participants |
Number of Participants According to Vital Status Within 30 Days of Discharge
The number of participants were classified according to the vital status in this outcome measure.
Time frame: Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants According to Vital Status Within 30 Days of Discharge | Participant is still alive | 126 Participants |
| Participants With CAP | Number of Participants According to Vital Status Within 30 Days of Discharge | Participant is deceased | 31 Participants |
| Participants With CAP | Number of Participants According to Vital Status Within 30 Days of Discharge | Unknown | 28 Participants |
| Participants With cSSTI | Number of Participants According to Vital Status Within 30 Days of Discharge | Participant is still alive | 98 Participants |
| Participants With cSSTI | Number of Participants According to Vital Status Within 30 Days of Discharge | Participant is deceased | 15 Participants |
| Participants With cSSTI | Number of Participants According to Vital Status Within 30 Days of Discharge | Unknown | 19 Participants |
Number of Participants Administered Zinforo as Monotherapy or Combination Therapy
The number of participants were classified according to Zinforo administration as monotherapy or combination therapy were reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants Administered Zinforo as Monotherapy or Combination Therapy | Monotherapy | 56 Participants |
| Participants With CAP | Number of Participants Administered Zinforo as Monotherapy or Combination Therapy | Combination therapy | 129 Participants |
| Participants With cSSTI | Number of Participants Administered Zinforo as Monotherapy or Combination Therapy | Monotherapy | 78 Participants |
| Participants With cSSTI | Number of Participants Administered Zinforo as Monotherapy or Combination Therapy | Combination therapy | 54 Participants |
Number of Participants Based on Treatment Response to Post-Zinforo Treatment
Clinical response in CAP:participants demonstrating clinical stability(i.e.,according to IDSA guidelines:temperature of\<=37.8 degree Celsius,heart rate of \<=100 beats per minute,respiratory rate of \<=24 breaths per minute,systolic blood pressure of \>=90 mmHg,oxygen saturation of \>=90%,confusion/disorientation recorded as absent),clinical improvement(i.e.,improvement of at least 1 of 4 symptoms present at Baseline(i.e.,cough,dyspnea,pleuritic chest pain,sputum production)with worsening of none).Clinical response in cSSTI participants:\>=20% reduction from baseline infection area,cessation of spread measured by total infection area.Clinical failure for both CAP and cSSTI:any of the following:treatment modification due to AE;drug-drug interaction;insufficient response(followed by switch);death due to index infection;death due to other cause;relapse or recurrence. Number of participants classified according to treatment responses to post-Zinforo treatment reported in this outcome measure.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants Based on Treatment Response to Post-Zinforo Treatment | Clinical response | 155 Participants |
| Participants With CAP | Number of Participants Based on Treatment Response to Post-Zinforo Treatment | Clinical failure | 26 Participants |
| Participants With CAP | Number of Participants Based on Treatment Response to Post-Zinforo Treatment | Unknown | 23 Participants |
| Participants With cSSTI | Number of Participants Based on Treatment Response to Post-Zinforo Treatment | Clinical response | 95 Participants |
| Participants With cSSTI | Number of Participants Based on Treatment Response to Post-Zinforo Treatment | Clinical failure | 4 Participants |
| Participants With cSSTI | Number of Participants Based on Treatment Response to Post-Zinforo Treatment | Unknown | 20 Participants |
Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization
Treatment response was defined according to the following criteria: CAP participants who demonstrated clinical stability (defined according to the Infectious Diseases Society of America \[IDSA\] guidelines as temperature of ≤37.8 C°, heart rate of ≤100 beats/min, respiratory rate of ≤24 breaths/min, systolic blood pressure of ≥90mmHg, oxygen saturation of ≥90%, and confusion/disorientation recorded as absent) and clinical improvement{defined as improvement of at least 1 of 4 symptoms present at baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none}. cSSTI participants: ≥20% reduction from baseline infection area and cessation of spread measured by total infection area. The number of participants were classified according to treatment response to pre-Zinforo treatment and were reported in this outcome measure.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization | Response | 12 Participants |
| Participants With CAP | Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization | No response | 89 Participants |
| Participants With CAP | Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization | Unknown | 33 Participants |
| Participants With cSSTI | Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization | Response | 17 Participants |
| Participants With cSSTI | Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization | No response | 14 Participants |
| Participants With cSSTI | Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization | Unknown | 62 Participants |
Number of Participants Receiving Concomitant Therapies Along With Zinforo
Number of participants who received concomitant therapies along with Zinforo were reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants Receiving Concomitant Therapies Along With Zinforo | 131 Participants |
| Participants With cSSTI | Number of Participants Receiving Concomitant Therapies Along With Zinforo | 92 Participants |
Number of Participants Requiring Isolation
The number of participants who required isolation were reported in this outcome measure.
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants Requiring Isolation | 20 Participants |
| Participants With cSSTI | Number of Participants Requiring Isolation | 10 Participants |
Number of Participants Who Achieved Clinical Cure
Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Participants who achieved clinical cure were reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants Who Achieved Clinical Cure | 115 Participants |
| Participants With cSSTI | Number of Participants Who Achieved Clinical Cure | 72 Participants |
Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment | 139 Participants |
| Participants With cSSTI | Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment | 89 Participants |
Number of Participants Who Received Home-Based Care Through a Healthcare Agency
The number of participants who received home-based care through a healthcare agency were reported in this outcome measure.
Time frame: Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants Who Received Home-Based Care Through a Healthcare Agency | 16 Participants |
| Participants With cSSTI | Number of Participants Who Received Home-Based Care Through a Healthcare Agency | 35 Participants |
Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition | Mechanical Ventilation | 56 Participants |
| Participants With CAP | Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition | Oxygen Therapy | 37 Participants |
| Participants With CAP | Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition | Parenteral Nutrition | 17 Participants |
| Participants With cSSTI | Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition | Mechanical Ventilation | 11 Participants |
| Participants With cSSTI | Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition | Oxygen Therapy | 6 Participants |
| Participants With cSSTI | Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition | Parenteral Nutrition | 5 Participants |
Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo
The number of participants who received renal replacement therapy after initiating treatment with Zinforo were reported in this outcome measure.
Time frame: Post initiation of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo | 5 Participants |
| Participants With cSSTI | Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo | 2 Participants |
Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement
The number of participants who suffered from acute renal failure and necessitated renal replacement were reported in this outcome measure.
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement | 11 Participants |
| Participants With cSSTI | Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement | 4 Participants |
Number of Participants With Clinical Failure
Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to adverse event (AE); drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Clinical Failure | 34 Participants |
| Participants With cSSTI | Number of Participants With Clinical Failure | 14 Participants |
Number of Participants With Clinical Response
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the Infectious Disease Society of America \[IDSA\] guidelines a temperature of less than or equal to (\<=) 37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of greater than or equal to (\>=) 90 millimeters of mercury (mmHg), oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Clinical Response | 151 Participants |
| Participants With cSSTI | Number of Participants With Clinical Response | 118 Participants |
Number of Participants With Development of Sepsis During Index Hospitalization
The number of participants who developed sepsis during index hospitalization were reported in this outcome measure.
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Development of Sepsis During Index Hospitalization | 38 Participants |
| Participants With cSSTI | Number of Participants With Development of Sepsis During Index Hospitalization | 29 Participants |
Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization
The number of participants who had hospitalization for any reason, 3 months before the index hospitalization were reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Time frame: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization | 34 Participants |
| Participants With cSSTI | Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization | 44 Participants |
Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization
The number of participants with insufficient response to pre-Zinforo treatment were reported in this outcome measure.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization | 58 Participants |
| Participants With cSSTI | Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization | 42 Participants |
Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization
The number of participants who had undergone surgical treatments, 3 months before to the index hospitalization were reported in this outcome measure.
Time frame: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization | 5 Participants |
| Participants With cSSTI | Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization | 24 Participants |
Number of Participants With Medical Conditions Presented at Index Hospitalization
The number of participants who had any medical conditions at the time of index hospitalization were reported in this outcome measure. Medical conditions that were considered included Human Immunodeficiency Virus (HIV) infection, alcohol abuse, cancer/malignancy, cerebrovascular disease, chronic dialysis within the past 30 days, chronic obstructive pulmonary disease, chronic renal disease, congestive heart failure, decompensated cirrhosis, diabetes mellitus, immunosuppressive disease, influenza, injection drug use, end stage liver disease, peripheral vascular disease, respiratory disease or any other relevant condition(s) or disease(s) that required chronic drug treatment. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Medical Conditions Presented at Index Hospitalization | 147 Participants |
| Participants With cSSTI | Number of Participants With Medical Conditions Presented at Index Hospitalization | 99 Participants |
Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization
The number of participants who had pre-Zinforo treatment modification were reported in this outcome measure.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization | 91 Participants |
| Participants With cSSTI | Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization | 60 Participants |
Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted
The qSOFA (also known as quickSOFA) was a bedside prompt that identified participants with suspected infection who are at greater risk for a poor outcome outside the intensive care unit (ICU). It used three criteria, assigning one point for low blood pressure Systolic blood pressure less than or equal to 100 millimeters of mercury (SBP\<=100 mmHg), high respiratory rate greater than or equal to (\>=) 22 breaths per min, or altered mentation (Glasgow coma scale\<15).
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted | 74 Participants |
| Participants With cSSTI | Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted | 40 Participants |
Number of Participants With Radiographic Findings in Tests for CAP
Participants were categorized according to radiographic findings in the tests conducted for diagnosis of CAP infection in this outcome measure. One participant could have more than one radiographic finding.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CAP | Number of Participants With Radiographic Findings in Tests for CAP | Infiltrate | 130 Participants |
| Participants With CAP | Number of Participants With Radiographic Findings in Tests for CAP | Consolidation | 68 Participants |
| Participants With CAP | Number of Participants With Radiographic Findings in Tests for CAP | Pleural effusion | 48 Participants |
| Participants With CAP | Number of Participants With Radiographic Findings in Tests for CAP | Other findings | 30 Participants |
| Participants With CAP | Number of Participants With Radiographic Findings in Tests for CAP | None of the above | 3 Participants |
Number of Participants With Recurrent CAP Infections at Index Hospitalization
The number of participants with recurrent CAP infections were reported in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Recurrent CAP Infections at Index Hospitalization | 10 Participants |
Number of Participants With Re-hospitalizations
The number of participants who had re-hospitalizations were reported in this outcome measure.
Time frame: Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Re-hospitalizations | 20 Participants |
| Participants With cSSTI | Number of Participants With Re-hospitalizations | 13 Participants |
Number of Participants With Re-hospitalization Within 30 Days of Discharge
The number of participants who were re-hospitalized within 30 days of discharge were reported in this outcome measure.
Time frame: Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Re-hospitalization Within 30 Days of Discharge | 20 Participants |
| Participants With cSSTI | Number of Participants With Re-hospitalization Within 30 Days of Discharge | 13 Participants |
Number of Participants With Serious Adverse Events
An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; hospitalization/prolongation of hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Serious Adverse Events | 0 Participants |
| Participants With cSSTI | Number of Participants With Serious Adverse Events | 2 Participants |
Number of Participants With Severe CAP
Number of participants diagnosed with severe CAP were reported in this outcome measure.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With CAP | Number of Participants With Severe CAP | 128 Participants |
Time From Admission to First Dose of Zinforo During Index Hospitalization
The time taken from admission to the administration of first dose of Zinforo was reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time From Admission to First Dose of Zinforo During Index Hospitalization | 1 Days |
| Participants With cSSTI | Time From Admission to First Dose of Zinforo During Index Hospitalization | 1 Days |
Time From Symptom Onset to First Dose of Pre-Zinforo Treatment
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time From Symptom Onset to First Dose of Pre-Zinforo Treatment | 3 Days |
| Participants With cSSTI | Time From Symptom Onset to First Dose of Pre-Zinforo Treatment | 2 Days |
Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization
The time taken for the symptom onset to the administration of first dose of Zinforo was reported in this outcome measure.
Time frame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization | 6 Days |
| Participants With cSSTI | Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization | 7 Days |
Time of CAP Diagnosis at Index Hospitalization
The time taken (in days) taken to diagnose CAP in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time of CAP Diagnosis at Index Hospitalization | 1 Days |
Time of cSSTI Diagnosis at Index Hospitalization
The time taken (in days) taken to diagnose cSSTI in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission.
Time frame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time of cSSTI Diagnosis at Index Hospitalization | 5 Days |
Time to Clinical Cure
Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Time taken to achieve the clinical cure was reported in this outcome measure.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time to Clinical Cure | 7 Days |
| Participants With cSSTI | Time to Clinical Cure | 5 Days |
Time to Clinical Response
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time to Clinical Response | 4 Days |
| Participants With cSSTI | Time to Clinical Response | 4 Days |
Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment
The time (days) taken for modification from initial dose of pre-Zinforo treatment were reported in this outcome measure.
Time frame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With CAP | Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment | 2 Days |
| Participants With cSSTI | Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment | 3 Days |
Total Dose of Other Antibiotics Administered Post Zinforo Treatment
Time frame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With CAP | Total Dose of Other Antibiotics Administered Post Zinforo Treatment | 11.05 Milligrams | Standard Deviation 14.82 |
| Participants With cSSTI | Total Dose of Other Antibiotics Administered Post Zinforo Treatment | 11.05 Milligrams | Standard Deviation 14.82 |
Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With CAP | Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo | 8.48 Doses | Standard Deviation 9.81 |
| Participants With cSSTI | Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo | 8.48 Doses | Standard Deviation 9.81 |
Total Number of Doses of Zinforo Administered
Time frame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With CAP | Total Number of Doses of Zinforo Administered | 18.96 Doses | Standard Deviation 11.05 |
| Participants With cSSTI | Total Number of Doses of Zinforo Administered | 23.29 Doses | Standard Deviation 18.2 |