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Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04198571
Enrollment
317
Registered
2019-12-13
Start date
2020-05-17
Completion date
2021-08-30
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Pneumonia, Complicated Skin and Soft Tissue Infection

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

DRUGZinforo (ceftaroline fosamil)

IV Solution

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number of Participants With Clinical ResponseDay 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 ResponseDay 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 CureDay 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 CureDay 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 FailureDay 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 FailureDay 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 FailureDay 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 StabilityDay 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 ImprovementBaseline (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 DaysWithin 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 DischargeWithin 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 DaysWithin 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 AreaBaseline (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 AreaDay 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 WidthDay 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 StatusAt 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 DischargeWithin 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) AssessmentFrom 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 HospitalizationFrom 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 PathogensFrom 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 EventsDay 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 HospitalizationAt 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 Hospitalization3 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 Hospitalization3 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 Hospitalization3 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 CAPAt 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 HospitalizationAt 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 CAPAt 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 SeverityAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 Hospitalization12 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationAt 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 HospitalizationBefore 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 HospitalizationBefore 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 HospitalizationBefore 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 HospitalizationBefore 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 TreatmentBefore 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 HospitalizationBefore 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 HopsitalizationBefore 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 HospitalizationBefore 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 ModificationBefore 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 HospitalizationBefore 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 TreatmentBefore 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 HospitalizationBefore 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 HospitalizationDay 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 HospitalizationDay 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 HospitalizationDuring 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 ZinforoDuring 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 ZinforoDay 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 ZinforoDay 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 AdministrationDay 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 TherapyDay 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 ZinforoDay 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 TreatmentPost 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 TreatmentPost 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 TreatmentCAP (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 TreatmentPost 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 TreatmentPost 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 TreatmentPost 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 TreatmentPost 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 AdministrationPost 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 TreatmentPost 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 TreatmentPost 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 HospitalizationDay 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 UnitDuring 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 ZinforoPost 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 HospitalizationDuring 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 AgencyWithin 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-hospitalizationsWithin 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-hospitalizationsDay 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-hozpitalizationDay 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 HospitalizationDuring 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) ConductedDuring 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 IsolationDuring 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 NutritionDuring 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 ReplacementDuring 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 AdministeredDay 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 ZinforoDay 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 TreatmentPost 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 HospitalizationDay 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

ArmCount
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
Total317

Baseline characteristics

CharacteristicParticipants With CAPParticipants With cSSTITotal
Age, Customized
18 to less than or equal to 65 years
90 Participants83 Participants173 Participants
Age, Customized
Greater than 65 years
95 Participants49 Participants144 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
76 Participants55 Participants131 Participants
Sex: Female, Male
Male
109 Participants77 Participants186 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
31 / 18515 / 132
other
Total, other adverse events
0 / 1850 / 132
serious
Total, serious adverse events
0 / 1852 / 132

Outcome results

Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPCAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index HospitalizationYes32 Participants
Participants With CAPCAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index HospitalizationNo64 Participants
Participants With CAPCAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index HospitalizationUnknown89 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPCAP: Number of Participants According to Pneumococcal Vaccination Status at Index HospitalizationYes18 Participants
Participants With CAPCAP: Number of Participants According to Pneumococcal Vaccination Status at Index HospitalizationNo76 Participants
Participants With CAPCAP: Number of Participants According to Pneumococcal Vaccination Status at Index HospitalizationUnknown91 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPCAP: Number of Participants According to Reasons for Clinical FailureDeath due to index infection7 Participants
Participants With CAPCAP: Number of Participants According to Reasons for Clinical FailureInsufficient response21 Participants
Participants With CAPCAP: Number of Participants According to Reasons for Clinical FailureDeath due to other2 Participants
Participants With CAPCAP: Number of Participants According to Reasons for Clinical FailureRelapse or recurrence2 Participants
Participants With CAPCAP: Number of Participants According to Reasons for Clinical FailureUnknown2 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPCAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index HospitalizationC-reactive protein (CRP)182 Participants
Participants With CAPCAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index HospitalizationProcalcitonin73 Participants
Participants With CAPCAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index HospitalizationOther biomarker8 Participants
Participants With CAPCAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index HospitalizationNone of the above2 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPCAP: Number of Participants With Early Response Within 4 Days79 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPCAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization71 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPCAP: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationNew or increased cough129 Participants
Participants With CAPCAP: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationPurulent sputum or change in sputum character80 Participants
Participants With CAPCAP: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationAuscultatory findings consistent with pneumonia138 Participants
Participants With CAPCAP: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationDyspnea, tachypnea, or hypoxemia (O2 saturation < 90% on room air or pO2 < 60 mmHg)148 Participants
Participants With CAPCAP: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationFever (>38 degree C oral; > 38.5 degree C rectally or tympanically) or hypothermia (< 35 degree C)127 Participants
Participants With CAPCAP: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationWBC count > 10,000 cells/mm³ or < 4,500 cells/mm³122 Participants
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPCAP Only: Time to Clinical Improvement3 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPCAP Only: Time to Clinical Stability3 Days
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Participants With CAPCost of HospitalizationStandard hospital cost9204.62 US dollarsStandard Deviation 12895.23
Participants With CAPCost of HospitalizationAdvanced level cost25408.01 US dollarsStandard Deviation 31704.58
Participants With cSSTICost of HospitalizationStandard hospital cost5196.2 US dollarsStandard Deviation 9070.35
Participants With cSSTICost of HospitalizationAdvanced level cost20257.18 US dollarsStandard Deviation 36809.71
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Area of Extension of Skin Infection at Index HospitalizationLess than (<) 5 centimeter square (cm^2)12 Participants
Participants With CAPcSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization5-10 cm^231 Participants
Participants With CAPcSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization10-50 cm^234 Participants
Participants With CAPcSSTI: Number of Participants According to Area of Extension of Skin Infection at Index HospitalizationGreater than (>) 50 cm^28 Participants
Participants With CAPcSSTI: Number of Participants According to Area of Extension of Skin Infection at Index HospitalizationUnknown47 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Level of Infections at Index HospitalizationSuperficial51 Participants
Participants With CAPcSSTI: Number of Participants According to Level of Infections at Index HospitalizationDeep incisional51 Participants
Participants With CAPcSSTI: Number of Participants According to Level of Infections at Index HospitalizationOrgan or space infection20 Participants
Participants With CAPcSSTI: Number of Participants According to Level of Infections at Index HospitalizationUnknown10 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationMethicillin resistance Staphylococcus aureus24 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationMethicillin susceptible S. aureus (MSSA)23 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationStaphylococcus coagulase negative8 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationStreptococcus pneumonia1 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationStreptococcus pyogenes4 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationStreptococcus agalactiae1 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationEnterococcus faecalis2 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationGram-negative bacilli12 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationNon-fermenting enterobacteria1 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationOther strict anaerobic bacteria1 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationOther microorganism8 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationMixed flora1 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationUnknown24 Participants
Participants With CAPcSSTI: Number of Participants According to Microbiologic Diagnosis at Index HospitalizationNone of the above40 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Reasons for Clinical FailureTreatment modification due to AE1 Participants
Participants With CAPcSSTI: Number of Participants According to Reasons for Clinical FailureInsufficient response10 Participants
Participants With CAPcSSTI: Number of Participants According to Reasons for Clinical FailureRelapse or recurrence3 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index HospitalizationEpithelium61 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index HospitalizationEpidermis92 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index HospitalizationDermis88 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index HospitalizationSubcutaneous fat61 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index HospitalizationFascia23 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index HospitalizationMuscle25 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index HospitalizationUnknown23 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationHead13 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationHand3 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationUpper extremities14 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationLower extremities74 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationThorax19 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationAbdomen14 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationGenitalia9 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Body Area Involved at Index HospitalizationUnknown1 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationBlood cultures85 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationSuperficial swab and culture40 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationNeedle aspiration14 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationSkin biopsy7 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationSurgical sample22 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationX-ray31 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationUltrasound58 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationComputed Tomography (CT)/ Magnetic Resonance Imaging (MRI)35 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index HospitalizationUnknown/not performed6 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationAbscess45 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationCellulitis/fasciitis82 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationPost-traumatic wound9 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationPost-surgical wound26 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationDecubitus ulcer5 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationDiabetic leg ulcer5 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationPeripheral vascular disease ulcer3 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationBite1 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationUnknown1 Participants
Participants With CAPcSSTI: Number of Participants According to Type of Lesions Involved at Index HospitalizationNone of the above2 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants With Early Response Within 3 Days20 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants With Recurrent Infection at Index Hospitalization33 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationPurulent or seropurulent drainage/discharge65 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationBullae5 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationErythema106 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationFluctuance30 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationHeat/localized warmth90 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationPain/tenderness to palpitation100 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationSwelling/induration78 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationSkin necrosis9 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationAnesthesia1 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationCrackling3 Participants
Participants With CAPcSSTI: Number of Participants With Triggering Signs and Symptoms at Index HospitalizationInduration beyond the erythematous area17 Participants
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPcSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width2 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPcSSTI Only: Time to Cessation of Spread Measured by Total Infection Area2 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPcSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area3 Days
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Participants With CAPDaily Dose of Zinforo1183.24 MilligramsStandard Deviation 412.69
Participants With cSSTIDaily Dose of Zinforo1239.39 MilligramsStandard Deviation 402.43
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPDay of MIC Assessment Since Index Hospitalization1 Days
Participants With cSSTIDay of MIC Assessment Since Index Hospitalization4 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPDuration From Zinforo Discontinuation to Initiation of New Treatment1 Days
Participants With cSSTIDuration From Zinforo Discontinuation to Initiation of New Treatment1 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPDuration in Intensive Care Unit0 Days
Participants With cSSTIDuration in Intensive Care Unit0 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPDuration of Index Hospitalization12 Days
Participants With cSSTIDuration of Index Hospitalization11 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPDuration of Pre-Zinforo Treatment During Index Hospitalization6 Days
Participants With cSSTIDuration of Pre-Zinforo Treatment During Index Hospitalization8 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPDuration of Re-hospitalizations10.5 Days
Participants With cSSTIDuration of Re-hospitalizations9 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPDuration of Zinforo Treatment During Index Hospitalization7 Days
Participants With cSSTIDuration of Zinforo Treatment During Index Hospitalization8 Days
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Participants With CAPNumber of Doses Administered for Post Zinforo Treatment11.05 DosesStandard Deviation 14.82
Participants With cSSTINumber of Doses Administered for Post Zinforo Treatment16.38 DosesStandard Deviation 21.81
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Participants With CAPNumber of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization2.02 DosesStandard Deviation 0.93
Participants With cSSTINumber of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization2.18 DosesStandard Deviation 1.54
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Participants With CAPNumber of Infusions Administered Daily for Zinforo2.28 InfusionsStandard Deviation 0.47
Participants With cSSTINumber of Infusions Administered Daily for Zinforo2.27 InfusionsStandard Deviation 0.46
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationICU70 Participants
Participants With CAPNumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationGeneral ward86 Participants
Participants With CAPNumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationAt home64 Participants
Participants With CAPNumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationOut-patient setting9 Participants
Participants With CAPNumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationMedical clinic6 Participants
Participants With CAPNumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationOther0 Participants
Participants With cSSTINumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationMedical clinic5 Participants
Participants With cSSTINumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationICU1 Participants
Participants With cSSTINumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationOut-patient setting16 Participants
Participants With cSSTINumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationGeneral ward42 Participants
Participants With cSSTINumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationOther1 Participants
Participants With cSSTINumber of Participant According to Type of Location for Post-Zinforo Treatment AdministrationAt home70 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationCarbapenem12 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationBetalactam/Combination36 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationCephalosporins19 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationQuinolone50 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationBetalactam17 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationSulfonamide37 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationGlycopeptide4 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationClindamycin1 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationCeftriaxone45 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationOther antibiotic agent15 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationMacrolide13 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationUnknown17 Participants
Participants With CAPNumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationAminoglycoside5 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationUnknown31 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationAminoglycoside6 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationBetalactam20 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationCarbapenem4 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationCeftriaxone10 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationCephalosporins16 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationGlycopeptide18 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationMacrolide23 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationBetalactam/Combination6 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationQuinolone21 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationSulfonamide10 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationClindamycin4 Participants
Participants With cSSTINumber of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index HospitalizationOther antibiotic agent8 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Discharge StatusDied in the hospital18 Participants
Participants With CAPNumber of Participants According to Discharge StatusDischarged to a nursing home or extended care facility28 Participants
Participants With CAPNumber of Participants According to Discharge StatusDischarged to independent living (with or without support)138 Participants
Participants With CAPNumber of Participants According to Discharge StatusOther1 Participants
Participants With cSSTINumber of Participants According to Discharge StatusOther2 Participants
Participants With cSSTINumber of Participants According to Discharge StatusDied in the hospital6 Participants
Participants With cSSTINumber of Participants According to Discharge StatusDischarged to independent living (with or without support)101 Participants
Participants With cSSTINumber of Participants According to Discharge StatusDischarged to a nursing home or extended care facility23 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationFirst134 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationSecond85 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationThird40 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationFourth20 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationFifth5 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationSixth2 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationSeventh1 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationEighth1 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationNineth0 Participants
Participants With CAPNumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationTenth0 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationEighth3 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationFirst87 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationSixth3 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationSecond58 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationTenth1 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationThird24 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationSeventh3 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationFourth13 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationNineth1 Participants
Participants With cSSTINumber of Participants According to Lines of Pre-Zinforo Therapies During Index HospitalizationFifth5 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentFirst1 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentSecond45 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentThird40 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentFourth51 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentFifth26 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentSixth25 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentSeventh5 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentEighth8 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentNineth3 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentTenth0 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentEleventh0 Participants
Participants With CAPNumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentTwelfth0 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentEleventh1 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentFirst2 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentSeventh5 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentSecond46 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentTenth1 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentThird20 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentEighth2 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentFourth21 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentTwelfth1 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentFifth11 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentNineth4 Participants
Participants With cSSTINumber of Participants According to Lines of Therapy for Post-Zinforo TreatmentSixth5 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Locations of Zinforo AdministrationGeneral ward115 Participants
Participants With CAPNumber of Participants According to Locations of Zinforo AdministrationMedical clinic30 Participants
Participants With CAPNumber of Participants According to Locations of Zinforo AdministrationAt home1 Participants
Participants With CAPNumber of Participants According to Locations of Zinforo AdministrationOut-patient setting0 Participants
Participants With CAPNumber of Participants According to Locations of Zinforo AdministrationIntensive Care Unit (ICU)66 Participants
Participants With cSSTINumber of Participants According to Locations of Zinforo AdministrationOut-patient setting2 Participants
Participants With cSSTINumber of Participants According to Locations of Zinforo AdministrationIntensive Care Unit (ICU)11 Participants
Participants With cSSTINumber of Participants According to Locations of Zinforo AdministrationGeneral ward114 Participants
Participants With cSSTINumber of Participants According to Locations of Zinforo AdministrationAt home14 Participants
Participants With cSSTINumber of Participants According to Locations of Zinforo AdministrationMedical clinic14 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of ceftaroline for all isolated pathogens5 Participants
Participants With CAPNumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of oxacillin, vancomycin, linezolid, and daptomycin for Staphylococcus aureus12 Participants
Participants With CAPNumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of ceftriaxone for Methicillin-Susceptible Staphylococcus aureus (MSSA)3 Participants
Participants With CAPNumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of penicillin and ceftriaxone for Streptococcus pneumonia10 Participants
Participants With cSSTINumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of penicillin and ceftriaxone for Streptococcus pneumonia0 Participants
Participants With cSSTINumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of ceftaroline for all isolated pathogens7 Participants
Participants With cSSTINumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of ceftriaxone for Methicillin-Susceptible Staphylococcus aureus (MSSA)6 Participants
Participants With cSSTINumber of Participants According to MIC of Antibacterial Drugs Assessed Based on PathogensMIC of oxacillin, vancomycin, linezolid, and daptomycin for Staphylococcus aureus20 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationStreptococcus pneumonia44 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationEscherichia coli2 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationHemophilus influenza3 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationH. Parainfluenza1 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationLegionella spp.2 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationStaphylococcus aureus4 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationMethicillin resistance Staphylococcus aureus14 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationMethicillin susceptible Staphylococcus. aureus15 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationKlebsiella pneumonia3 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationOther enterobacteria2 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationPseudomonas aeruginosa1 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationOther microorganism26 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationUnknown15 Participants
Participants With CAPNumber of Participants According to Microbiological CAP Diagnosis at Index HospitalizationNone of the above72 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Minimum Inhibitory Concentration (MIC) AssessmentYes23 Participants
Participants With CAPNumber of Participants According to Minimum Inhibitory Concentration (MIC) AssessmentNo161 Participants
Participants With CAPNumber of Participants According to Minimum Inhibitory Concentration (MIC) AssessmentUnknown1 Participants
Participants With cSSTINumber of Participants According to Minimum Inhibitory Concentration (MIC) AssessmentYes28 Participants
Participants With cSSTINumber of Participants According to Minimum Inhibitory Concentration (MIC) AssessmentNo94 Participants
Participants With cSSTINumber of Participants According to Minimum Inhibitory Concentration (MIC) AssessmentUnknown10 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentInsufficient response14 Participants
Participants With CAPNumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentDeath due to infection6 Participants
Participants With CAPNumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentRelapse/reoccurrence1 Participants
Participants With CAPNumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentDeath due to other3 Participants
Participants With CAPNumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentTreatment modification due to adverse event2 Participants
Participants With cSSTINumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentDeath due to other3 Participants
Participants With cSSTINumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentTreatment modification due to adverse event0 Participants
Participants With cSSTINumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentInsufficient response1 Participants
Participants With cSSTINumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentRelapse/reoccurrence0 Participants
Participants With cSSTINumber of Participants According to Reasons for Clinical Failure to Post-Zinforo TreatmentDeath due to infection0 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationInsufficient response58 Participants
Participants With CAPNumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationStreamlining29 Participants
Participants With CAPNumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationPossible interaction with other drug1 Participants
Participants With CAPNumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationOther14 Participants
Participants With CAPNumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationAdverse event5 Participants
Participants With cSSTINumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationOther16 Participants
Participants With cSSTINumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationAdverse event3 Participants
Participants With cSSTINumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationInsufficient response42 Participants
Participants With cSSTINumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationPossible interaction with other drug1 Participants
Participants With cSSTINumber of Participants According to Reasons for Pre-Zinforo Treatment ModificationStreamlining9 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Reasons for Re-hozpitalizationFor index infection7 Participants
Participants With CAPNumber of Participants According to Reasons for Re-hozpitalizationFor other reason13 Participants
Participants With cSSTINumber of Participants According to Reasons for Re-hozpitalizationFor index infection3 Participants
Participants With cSSTINumber of Participants According to Reasons for Re-hozpitalizationFor other reason10 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentSide effect of previous treatment1 Participants
Participants With CAPNumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentOther124 Participants
Participants With CAPNumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentResults of susceptibility test/pathogen identification26 Participants
Participants With CAPNumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentUnknown14 Participants
Participants With CAPNumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentLack of efficacy of previous treatment39 Participants
Participants With cSSTINumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentUnknown6 Participants
Participants With cSSTINumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentLack of efficacy of previous treatment9 Participants
Participants With cSSTINumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentSide effect of previous treatment9 Participants
Participants With cSSTINumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentResults of susceptibility test/pathogen identification14 Participants
Participants With cSSTINumber of Participants According to Reasons for Switching to Post-Zinforo TreatmentOther81 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Route of Administration for Post-Zinforo TreatmentOral92 Participants
Participants With CAPNumber of Participants According to Route of Administration for Post-Zinforo TreatmentIntra-venous112 Participants
Participants With cSSTINumber of Participants According to Route of Administration for Post-Zinforo TreatmentOral81 Participants
Participants With cSSTINumber of Participants According to Route of Administration for Post-Zinforo TreatmentIntra-venous38 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationIntra-venous111 Participants
Participants With CAPNumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationSubcutaneous0 Participants
Participants With CAPNumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationIntra-muscular7 Participants
Participants With CAPNumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationUnknown4 Participants
Participants With CAPNumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationOral44 Participants
Participants With cSSTINumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationUnknown3 Participants
Participants With cSSTINumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationOral31 Participants
Participants With cSSTINumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationIntra-venous73 Participants
Participants With cSSTINumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationIntra-muscular0 Participants
Participants With cSSTINumber of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index HospitalizationSubcutaneous1 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Systemic Signs of cSSTI at Index HospitalizationTemperature > 38 degree Celsius77 Participants
Participants With CAPNumber of Participants According to Systemic Signs of cSSTI at Index HospitalizationWhite blood cell count108 Participants
Participants With CAPNumber of Participants According to Systemic Signs of cSSTI at Index HospitalizationSeptic shock4 Participants
Participants With CAPNumber of Participants According to Systemic Signs of cSSTI at Index HospitalizationOrgan dysfunction13 Participants
Participants With CAPNumber of Participants According to Systemic Signs of cSSTI at Index HospitalizationNone of the above1 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationAnticoagulants38 Participants
Participants With CAPNumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationHome infusion therapy3 Participants
Participants With CAPNumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationImmunosuppressors/ immunomodulators21 Participants
Participants With CAPNumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationHome wound care provided by a medical professional6 Participants
Participants With CAPNumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationNon-steroid anti-inflammatory agents (NSAIs)13 Participants
Participants With CAPNumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationNone103 Participants
Participants With CAPNumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationAntimicrobial (e.g. antibiotics, antivirals)47 Participants
Participants With cSSTINumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationNone39 Participants
Participants With cSSTINumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationAntimicrobial (e.g. antibiotics, antivirals)56 Participants
Participants With cSSTINumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationImmunosuppressors/ immunomodulators19 Participants
Participants With cSSTINumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationAnticoagulants45 Participants
Participants With cSSTINumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationNon-steroid anti-inflammatory agents (NSAIs)25 Participants
Participants With cSSTINumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationHome infusion therapy2 Participants
Participants With cSSTINumber of Participants According to Therapies Received in the 3 Months Before the Index HospitalizationHome wound care provided by a medical professional5 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support44 Participants
Participants With CAPNumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support: Vasopressors44 Participants
Participants With CAPNumber of Participants According to Treatments Received During Index HospitalizationSurgery unrelated to the infection1 Participants
Participants With CAPNumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support: Invasive procedures2 Participants
Participants With CAPNumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support: Fluid resuscitation32 Participants
Participants With CAPNumber of Participants According to Treatments Received During Index HospitalizationNone of the above139 Participants
Participants With CAPNumber of Participants According to Treatments Received During Index HospitalizationSurgery related to the infection5 Participants
Participants With cSSTINumber of Participants According to Treatments Received During Index HospitalizationNone of the above90 Participants
Participants With cSSTINumber of Participants According to Treatments Received During Index HospitalizationSurgery related to the infection37 Participants
Participants With cSSTINumber of Participants According to Treatments Received During Index HospitalizationSurgery unrelated to the infection0 Participants
Participants With cSSTINumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support12 Participants
Participants With cSSTINumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support: Fluid resuscitation7 Participants
Participants With cSSTINumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support: Vasopressors10 Participants
Participants With cSSTINumber of Participants According to Treatments Received During Index HospitalizationBlood pressure support: Invasive procedures0 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentCarbapenem8 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentQuinolone45 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentGlycopeptide7 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentSulfonamide12 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentBetalactam13 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentClindamycin32 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentMacrolide12 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentOther antibiotic agent12 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentCeftriaxone18 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentLinezolid0 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentBetalactam/Combination27 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentUnknown9 Participants
Participants With CAPNumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentAminoglycoside9 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentUnknown0 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentAminoglycoside3 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentBetalactam4 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentCarbapenem5 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentCeftriaxone15 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentGlycopeptide5 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentMacrolide2 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentBetalactam/Combination12 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentQuinolone28 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentSulfonamide2 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentClindamycin21 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentOther antibiotic agent20 Participants
Participants With cSSTINumber of Participants According to Type of Antibiotics Received for Index Infection After Zinforo TreatmentLinezolid2 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index HospitalizationSputum examination33 Participants
Participants With CAPNumber of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index HospitalizationBlood culture39 Participants
Participants With CAPNumber of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index HospitalizationBronchoalveolar lavage or bronchial brush examination10 Participants
Participants With CAPNumber of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index HospitalizationPleural fluid sample examination4 Participants
Participants With CAPNumber of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index HospitalizationLegionella antigen test in urine5 Participants
Participants With CAPNumber of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index HospitalizationPneumococcal antigen test in urine30 Participants
Participants With CAPNumber of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index HospitalizationOther17 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Type of Prognostic Scoring System Used to Assess CAP SeverityPORT Score / Pneumonia Severity Index18 Participants
Participants With CAPNumber of Participants According to Type of Prognostic Scoring System Used to Assess CAP SeverityCURB-6541 Participants
Participants With CAPNumber of Participants According to Type of Prognostic Scoring System Used to Assess CAP SeverityOther15 Participants
Participants With CAPNumber of Participants According to Type of Prognostic Scoring System Used to Assess CAP SeverityNone71 Participants
Participants With CAPNumber of Participants According to Type of Prognostic Scoring System Used to Assess CAP SeverityUnknown40 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Types of Pre-Zinforo Treatment During Index HospitalizationEmpiric129 Participants
Participants With CAPNumber of Participants According to Types of Pre-Zinforo Treatment During Index HospitalizationDefinitive/Specific13 Participants
Participants With CAPNumber of Participants According to Types of Pre-Zinforo Treatment During Index HospitalizationUnknown6 Participants
Participants With cSSTINumber of Participants According to Types of Pre-Zinforo Treatment During Index HospitalizationEmpiric74 Participants
Participants With cSSTINumber of Participants According to Types of Pre-Zinforo Treatment During Index HospitalizationDefinitive/Specific19 Participants
Participants With cSSTINumber of Participants According to Types of Pre-Zinforo Treatment During Index HospitalizationUnknown10 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Types of Treatment for ZinforoEmpiric138 Participants
Participants With CAPNumber of Participants According to Types of Treatment for ZinforoDefinitive/Specific41 Participants
Participants With CAPNumber of Participants According to Types of Treatment for ZinforoUnknown6 Participants
Participants With cSSTINumber of Participants According to Types of Treatment for ZinforoEmpiric84 Participants
Participants With cSSTINumber of Participants According to Types of Treatment for ZinforoDefinitive/Specific43 Participants
Participants With cSSTINumber of Participants According to Types of Treatment for ZinforoUnknown5 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants According to Vital Status Within 30 Days of DischargeParticipant is still alive126 Participants
Participants With CAPNumber of Participants According to Vital Status Within 30 Days of DischargeParticipant is deceased31 Participants
Participants With CAPNumber of Participants According to Vital Status Within 30 Days of DischargeUnknown28 Participants
Participants With cSSTINumber of Participants According to Vital Status Within 30 Days of DischargeParticipant is still alive98 Participants
Participants With cSSTINumber of Participants According to Vital Status Within 30 Days of DischargeParticipant is deceased15 Participants
Participants With cSSTINumber of Participants According to Vital Status Within 30 Days of DischargeUnknown19 Participants
Primary

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Administered Zinforo as Monotherapy or Combination TherapyMonotherapy56 Participants
Participants With CAPNumber of Participants Administered Zinforo as Monotherapy or Combination TherapyCombination therapy129 Participants
Participants With cSSTINumber of Participants Administered Zinforo as Monotherapy or Combination TherapyMonotherapy78 Participants
Participants With cSSTINumber of Participants Administered Zinforo as Monotherapy or Combination TherapyCombination therapy54 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Based on Treatment Response to Post-Zinforo TreatmentClinical response155 Participants
Participants With CAPNumber of Participants Based on Treatment Response to Post-Zinforo TreatmentClinical failure26 Participants
Participants With CAPNumber of Participants Based on Treatment Response to Post-Zinforo TreatmentUnknown23 Participants
Participants With cSSTINumber of Participants Based on Treatment Response to Post-Zinforo TreatmentClinical response95 Participants
Participants With cSSTINumber of Participants Based on Treatment Response to Post-Zinforo TreatmentClinical failure4 Participants
Participants With cSSTINumber of Participants Based on Treatment Response to Post-Zinforo TreatmentUnknown20 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index HospitalizationResponse12 Participants
Participants With CAPNumber of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index HospitalizationNo response89 Participants
Participants With CAPNumber of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index HospitalizationUnknown33 Participants
Participants With cSSTINumber of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index HospitalizationResponse17 Participants
Participants With cSSTINumber of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index HospitalizationNo response14 Participants
Participants With cSSTINumber of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index HospitalizationUnknown62 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Receiving Concomitant Therapies Along With Zinforo131 Participants
Participants With cSSTINumber of Participants Receiving Concomitant Therapies Along With Zinforo92 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Requiring Isolation20 Participants
Participants With cSSTINumber of Participants Requiring Isolation10 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Who Achieved Clinical Cure115 Participants
Participants With cSSTINumber of Participants Who Achieved Clinical Cure72 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Who Achieved Clinical Response to Post-Zinforo Treatment139 Participants
Participants With cSSTINumber of Participants Who Achieved Clinical Response to Post-Zinforo Treatment89 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Who Received Home-Based Care Through a Healthcare Agency16 Participants
Participants With cSSTINumber of Participants Who Received Home-Based Care Through a Healthcare Agency35 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral NutritionMechanical Ventilation56 Participants
Participants With CAPNumber of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral NutritionOxygen Therapy37 Participants
Participants With CAPNumber of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral NutritionParenteral Nutrition17 Participants
Participants With cSSTINumber of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral NutritionMechanical Ventilation11 Participants
Participants With cSSTINumber of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral NutritionOxygen Therapy6 Participants
Participants With cSSTINumber of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral NutritionParenteral Nutrition5 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo5 Participants
Participants With cSSTINumber of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo2 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement11 Participants
Participants With cSSTINumber of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement4 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Clinical Failure34 Participants
Participants With cSSTINumber of Participants With Clinical Failure14 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Clinical Response151 Participants
Participants With cSSTINumber of Participants With Clinical Response118 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Development of Sepsis During Index Hospitalization38 Participants
Participants With cSSTINumber of Participants With Development of Sepsis During Index Hospitalization29 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization34 Participants
Participants With cSSTINumber of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization44 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization58 Participants
Participants With cSSTINumber of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization42 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization5 Participants
Participants With cSSTINumber of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization24 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Medical Conditions Presented at Index Hospitalization147 Participants
Participants With cSSTINumber of Participants With Medical Conditions Presented at Index Hospitalization99 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization91 Participants
Participants With cSSTINumber of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization60 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted74 Participants
Participants With cSSTINumber of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted40 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Radiographic Findings in Tests for CAPInfiltrate130 Participants
Participants With CAPNumber of Participants With Radiographic Findings in Tests for CAPConsolidation68 Participants
Participants With CAPNumber of Participants With Radiographic Findings in Tests for CAPPleural effusion48 Participants
Participants With CAPNumber of Participants With Radiographic Findings in Tests for CAPOther findings30 Participants
Participants With CAPNumber of Participants With Radiographic Findings in Tests for CAPNone of the above3 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Recurrent CAP Infections at Index Hospitalization10 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Re-hospitalizations20 Participants
Participants With cSSTINumber of Participants With Re-hospitalizations13 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Re-hospitalization Within 30 Days of Discharge20 Participants
Participants With cSSTINumber of Participants With Re-hospitalization Within 30 Days of Discharge13 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Serious Adverse Events0 Participants
Participants With cSSTINumber of Participants With Serious Adverse Events2 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With CAPNumber of Participants With Severe CAP128 Participants
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime From Admission to First Dose of Zinforo During Index Hospitalization1 Days
Participants With cSSTITime From Admission to First Dose of Zinforo During Index Hospitalization1 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime From Symptom Onset to First Dose of Pre-Zinforo Treatment3 Days
Participants With cSSTITime From Symptom Onset to First Dose of Pre-Zinforo Treatment2 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime From Symptom Onset to First Dose of Zinforo During Index Hospitalization6 Days
Participants With cSSTITime From Symptom Onset to First Dose of Zinforo During Index Hospitalization7 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime of CAP Diagnosis at Index Hospitalization1 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime of cSSTI Diagnosis at Index Hospitalization5 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime to Clinical Cure7 Days
Participants With cSSTITime to Clinical Cure5 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime to Clinical Response4 Days
Participants With cSSTITime to Clinical Response4 Days
Primary

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.

ArmMeasureValue (MEDIAN)
Participants With CAPTime to Treatment Modification From Initial Dose of Pre-Zinforo Treatment2 Days
Participants With cSSTITime to Treatment Modification From Initial Dose of Pre-Zinforo Treatment3 Days
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Participants With CAPTotal Dose of Other Antibiotics Administered Post Zinforo Treatment11.05 MilligramsStandard Deviation 14.82
Participants With cSSTITotal Dose of Other Antibiotics Administered Post Zinforo Treatment11.05 MilligramsStandard Deviation 14.82
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Participants With CAPTotal Number of Doses of Other Antibiotics Administered in Combination With Zinforo8.48 DosesStandard Deviation 9.81
Participants With cSSTITotal Number of Doses of Other Antibiotics Administered in Combination With Zinforo8.48 DosesStandard Deviation 9.81
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Participants With CAPTotal Number of Doses of Zinforo Administered18.96 DosesStandard Deviation 11.05
Participants With cSSTITotal Number of Doses of Zinforo Administered23.29 DosesStandard Deviation 18.2

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026