Infection
Conditions
Keywords
ceftazidime-avibactam, Zavicefta
Brief summary
This is a non-interventional medical chart review study aiming to examine the treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and Mexico), with possible expansion to other countries as ceftazidime-avibactam is launched. Eligible patients are adults who have been treated with ceftazidime-avibactam in routine practice at participating sites since 01 January, 2018 onwards or since the date of launch in the country if it is posterior to 01 January, 2018. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.
Detailed description
This observational study will include approximately 700 hospitalized patients with a gram-negative infection, who have received at least one dose of ceftazidime-avibactam. Patients will be recruited in approximately 62 sites across 12 countries in Europe (including Russia) and Latin America. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurs first. Data will be abstracted from medical records using an electronic case report form (eCRF). Baseline data include patient socio-demographics, medical history, and clinical and microbiological characteristics of the infection treated. Follow-up data will include details of treatment over time and clinical, microbiological, and healthcare resource utilization outcomes. Evaluation of clinical success will be performed in patients with at least ≥72 hours of exposure to ceftazidime-avibactam. Safety will be evaluated in all patients exposed to at least one dose of the product.
Interventions
OTHERZavicefta Treatment
Non-interventional - Retrospective Chart Review
Sponsors
Pfizer
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. Hospitalized patient ≥18 years old or considered an adult in accordance with the age of majority in the participant's country of residence at the time of treatment with ceftazidime-avibactam. 2. Patient received ≥1 dose of ceftazidime-avibactam in routine practice at participating site since 01 January, 2018 onwards or since the date of launch in the country if it is after 01 January, 2018. 3. Patient underwent microbiologic sampling ≤5 days before the initiation of ceftazidime-avibactam (irrespective of results and actual bacteriological identification). 4. Patient has all required essential data elements which include: 1. Start and stop dates of ceftazidime-avibactam, 2. Start and stop dates of prior antibiotic therapy used for the index infection, 3. Type of combined antibiotic therapy (if applicable) and start and stop dates of any antibiotic combined with ceftazidime-avibactam. 5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study where required by local regulations.
Exclusion criteria
Patients must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure. Index date was start date of ceftazidime-avibactam. |
| Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population | From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure. |
| Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received. |
| Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population | From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received. |
| Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Number of participants classified according to frequency of dose (once daily \[OD\], every other day \[QOD\], post-dialysis, each 48 hours \[h\], three times daily \[TID\], twice daily \[BD\], four times daily \[QID\], once loading dose \[an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose\], every three days, once, etc.,) for ceftazidime-avibactam were reported in this outcome measure. |
| Number of Participants Classified According to Frequency of Dosing: FAS72- Population | From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Number of participants classified according to frequency of dose (once daily \[OD\], every other day \[QOD\], each 48 hours \[h\], continuous infusion per 48 hours \[c/48 h\], three times daily \[TID\], twice daily \[BD\], four times daily \[QID\], one dose, loading dose \[an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose\] etc.,) for ceftazidime-avibactam were reported in this outcome measure. |
| Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1. |
| Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population | From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1. |
| Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure. |
| Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure. |
| Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to antibiotics used concurrently with ceftazidime-avibactam were reported in this outcome measure. Participants could have received more than 1 antibiotic. |
| Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to reason for initiating specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for initiating antibiotics. |
| Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to reason for discontinuing specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for discontinuing antibiotics. |
| Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population | From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study) | The number of participants whose samples were taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure. |
| Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to the type of specimen taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure. More than 1 type of specimen could have been taken from 1 participant. |
| Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to the pathogens identified from the microbiological culture after treatment initiation were reported in this outcome measure. |
| Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study) | The number of gram-negative pathogens according to the susceptibility to specific antibiotics after treatment initiation were reported in this outcome measure. |
| Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study) | Multi-drug resistance was defined as the isolate being non-susceptible to at least one agent in more than or equal to (\>=) 3 antimicrobial categories, excluding the therapeutic classes to which the pathogen was intrinsically resistant. The number of gram-negative pathogens classified according to the antibiotic resistance to specified antibiotics after treatment initiation were reported in this outcome measure. |
| Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population | At initial hospitalization (from the data evaluated in approximately 40 months of this study) | The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success. |
| Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population | 60 days after hospital discharge (from the data evaluated in approximately 40 months of this study) | The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success. |
| Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population | 60 days post treatment (from the data evaluated in approximately 40 months of this study) | The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success. |
| Number of Participants With Microbiological Treatment Outcome as Success: MOD Population | Up to 14 days post first dose of ceftazidime-avibactam (from the data evaluated in approximately 40 months of the study) | The number of participants with microbiological treatment outcome as success were reported in this outcome measure. Success was defined as: absence of causative pathogen from appropriately obtained specimens at the site of infection. |
| Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population | Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study) | The number of participants classified according to antibiotics used (Yes or No) for current infection before ceftazidime-avibactam were reported in this outcome measure. |
| Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study) | The number of participants classified according to reason for discontinuing for prior antibiotic therapy were reported in this outcome measure. One participant could have more than 1 reason of discontinuation for prior antibiotic therapy. |
| Percentage of Participants Who Died During Index Hospitalization | During index hospitalization, maximum of 418 days (from the data evaluated in approximately 40 months of this study) | In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure. |
| Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population | From index treatment up to 30 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study) | 30-day mortality was defined as deaths occurred from index treatment up to within 30 days after hospital discharge including in-hospital mortality. |
| Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population | From index treatment up to 60 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study) | 60-day mortality was defined as deaths occurred from index treatment up to within 60 days after hospital discharge including in-hospital mortality. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. AE included both SAEs and non-SAEs. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. Only AEs and SAEs with explicit attribution to ceftazidime-avibactam that appeared in the reviewed information and scenarios involving drug exposure to ceftazidime-avibactam, which included exposure during pregnancy, exposure during breastfeeding, medication error, overdose, misuse, extravasation, lack of efficacy and occupational exposure associated with the use of ceftazidime-avibactam were collected in the study. |
| Duration of Hospital Stay: FAS72+ Population | From index date up to hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 418 days (from the data evaluated in approximately 40 months of the study) | Hospital length of stay (LOS) was defined as date of hospital discharge minus date of hospital admission plus 1. The duration of hospital stay of participants were reported in this outcome measure. |
| Total Duration of ICU Stay: FAS72+ Population | During index hospitalization, maximum up to 418 days (from the data evaluated in approximately 40 months of the study) | Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The total duration of ICU stay of participants were reported in this outcome measure. |
| Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population | Up to 30 days after initial discharge (from the data evaluated in approximately 40 months of the study) | The number of participants readmitted to the hospital during the 30 days after initial discharge were reported in this outcome measure. |
| Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population | Up to 60 days after initial discharge (from the data evaluated in approximately 40 months of the study) | The number of participants readmitted to the hospital during the 60 days after initial discharge were reported in this outcome measure. |
| Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population | At readmission to the hospital, up to maximum of 60 days post initial hospital discharge (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to the reason for readmission to the hospital were reported in this outcome measure. One participant could have more than 1 reason for readmission to the hospital. |
| Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to the healthcare resource utilization during the hospitalization were reported in this outcome measure. One participant could have utilized more than 1 healthcare resource during hospitalization. |
| Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population | During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study) | The number of participants classified according to all wards attended during hospitalization were reported in this outcome measure. |
Countries
Argentina, Austria, Brazil, Colombia, France, Germany, Greece, Italy, Russia, Spain, United Kingdom
Participant flow
Recruitment details
Participants who were hospitalized with gram-negative infection and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study. Participants were recruited across Europe and Latin America and were followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurred first.
Pre-assignment details
Data was abstracted from medical records and evaluated over approximately 40 months of this study.
Participants by arm
| Arm | Count |
|---|---|
| Ceftazidime-avibactam Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study. | 569 |
| Total | 569 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 107 |
| Overall Study | Incomplete response to question | 13 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Other | 19 |
Baseline characteristics
| Characteristic | Ceftazidime-avibactam | — |
|---|---|---|
| Acute Physiology and Chronic Health Evaluation (APACHE) II Score | 19.5 Scores on a scale STANDARD_DEVIATION 7.93 | — |
| Age, Continuous FAS72- | 59.7 Years STANDARD_DEVIATION 17.99 | — |
| Age, Continuous FAS72+ | 58.3 Years STANDARD_DEVIATION 18.37 | — |
| Height: FAS72+ Analysis set | 169.9 Centimeter (cm) STANDARD_DEVIATION 9.35 | — |
| Number of Alcoholic Drinks per Week: FAS72+ Analysis set | 15.4 Drinks per week STANDARD_DEVIATION 17.36 | — |
| Number of Cigarettes per day For current smokers | 20.4 Cigarettes per day STANDARD_DEVIATION 8.76 | — |
| Number of Cigarettes per day For previous smokers | 19.6 Cigarettes per day STANDARD_DEVIATION 13.27 | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Aminoglycosides | 49 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Carbapenems | 118 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Cephalosporins | 73 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Fluoroquinolones | 65 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Glycopeptides | 81 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Glycylcycline | 17 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Lipopeptides | 17 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Macrolides | 24 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Monobactam | 5 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Nitroimidazole | 26 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Other agents | 65 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Oxazolidinones | 27 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Penicillins | 18 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Penicillins and beta-lactamase inhibitors | 110 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Tetracycline | 9 Participants | — |
| Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation Uncoded | 48 Participants | — |
| Number of Participants According to Country Travelled Within the Past 3 Months Egypt | 1 Participants | — |
| Number of Participants According to Country Travelled Within the Past 3 Months Germany | 1 Participants | — |
| Number of Participants According to Country Travelled Within the Past 3 Months Italy | 1 Participants | — |
| Number of Participants According to Country Travelled Within the Past 3 Months Netherlands | 1 Participants | — |
| Number of Participants According to Country Travelled Within the Past 3 Months Pakistan | 1 Participants | — |
| Number of Participants According to Country Travelled Within the Past 3 Months Spain | 2 Participants | — |
| Number of Participants According to Country Travelled Within the Past 3 Months Turkey | 1 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72- Complicated Intra-Abdominal Infection (cIAI) | 12 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72- Complicated Urinary Tract Infection (cUTI) | 7 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72- Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia (HAP/VAP) | 10 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72- Other | 24 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72+ Complicated Intra-Abdominal Infection (cIAI) | 90 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72+ Complicated Urinary Tract Infection (cUTI) | 103 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72+ Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia (HAP/VAP) | 114 Participants | — |
| Number of Participants According to Indication for Ceftazidime-Avibactam FAS72+ Other | 209 Participants | — |
| Number of Participants According to Initial Site of Infection Bladder | 2 Participants | — |
| Number of Participants According to Initial Site of Infection Gall Bladder | 2 Participants | — |
| Number of Participants According to Initial Site of Infection Kidney | 2 Participants | — |
| Number of Participants According to Initial Site of Infection Large Intestine | 5 Participants | — |
| Number of Participants According to Initial Site of Infection Liver | 2 Participants | — |
| Number of Participants According to Initial Site of Infection Lungs | 29 Participants | — |
| Number of Participants According to Initial Site of Infection Other | 103 Participants | — |
| Number of Participants According to Initial Site of Infection Pancreas | 1 Participants | — |
| Number of Participants According to Initial Site of Infection Peritoneum | 4 Participants | — |
| Number of Participants According to Initial Site of Infection Small Intestine | 2 Participants | — |
| Number of Participants According to Initial Site of Infection Urethra | 11 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Bloodstream infection (BSI)/ Sepsis | 97 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Central line associated blood stream infection (CLABSI) | 15 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Endocarditis | 0 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Febrile neutropenia | 24 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Meningitis | 0 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Osteomyelitis | 7 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Other | 51 Participants | — |
| Number of Participants According to Other Indication for Ceftazidime-Avibactam Surgical site infection (SSI) | 15 Participants | — |
| Number of Participants According to Source of Infection Community-acquired infection (CAI) | 46 Participants | — |
| Number of Participants According to Source of Infection Healthcare-associated infections (HCAI) | 116 Participants | — |
| Number of Participants According to Source of Infection Hospital-acquired infections (HAI) | 354 Participants | — |
| Number of Participants According to Their Employment Status Full Time | 78 Participants | — |
| Number of Participants According to Their Employment Status Not Available | 207 Participants | — |
| Number of Participants According to Their Employment Status Part Time | 5 Participants | — |
| Number of Participants According to Their Employment Status Retired | 159 Participants | — |
| Number of Participants According to Their Employment Status Unemployed | 67 Participants | — |
| Number of Participants According to Tobacco use Current Smoker | 38 Participants | — |
| Number of Participants According to Tobacco use Never Smoked | 165 Participants | — |
| Number of Participants According to Tobacco use Previous Smoker | 88 Participants | — |
| Number of Participants According to Tobacco use Unknown | 225 Participants | — |
| Number of Participants With Alcohol use | 41 Participants | — |
| Number of Participants With Antibiotic Exposure Within 90 Days Prior to Index Hospitalization | 260 Participants | — |
| Number of Participants With any Healthcare Procedure Within 30 Days Prior to Index Date | 311 Participants | — |
| Number of Participants With Comorbidities Any comorbidities | 479 Participants | — |
| Number of Participants With Comorbidities No comorbidities | 37 Participants | — |
| Number of Participants With Microbiological Cultures Performed for Current Infection Before Therapy | 239 Participants | — |
| Number of Participants With Prior Hospitalizations Within 90 days Prior to Current Hospitalization | 253 Participants | — |
| Number of Participants With Reported Pregnancy | 3 Participants | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Anaerobes: Bacteroides spp | 1 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Acinetobacter baumannii | 16 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Acinetobacter spp | 1 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Citrobacter spp | 1 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Enterobacter cloacae | 17 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Enterobacter spp | 5 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Escherichia coli | 21 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Haemophilus spp | 1 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Klebsiella pneumoniae | 140 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Klebsiella species (spp) | 25 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Morganella morganii | 2 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Other | 9 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Proteus mirabilis | 6 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Proteus spp | 1 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Pseudomonas aeruginosa | 30 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Pseudomonas spp | 3 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-negative: Serratia spp | 3 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-positive: Enterococcus spp | 23 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-positive: Other | 10 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-positive: Staphylococcus aureus | 7 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-positive: Staphylococcus spp | 5 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Gram-positive: Streptococcus spp | 5 Pathogens | — |
| Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy Other Bacterial Agent | 3 Pathogens | — |
| Number of Weeks of Gestation Since Last Menstrual Period | 29.7 Weeks STANDARD_DEVIATION 8.39 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male FAS72- Female | 20 Participants | — |
| Sex: Female, Male FAS72- Male | 33 Participants | — |
| Sex: Female, Male FAS72+ Female | 164 Participants | — |
| Sex: Female, Male FAS72+ Male | 352 Participants | — |
| Weight: FAS72+ Analysis set | 76.0 Kilogram (kg) STANDARD_DEVIATION 19.15 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 170 / 569 |
| other Total, other adverse events | 2 / 569 |
| serious Total, serious adverse events | 5 / 569 |
Outcome results
Primary
Duration of Hospital Stay: FAS72+ Population
Hospital length of stay (LOS) was defined as date of hospital discharge minus date of hospital admission plus 1. The duration of hospital stay of participants were reported in this outcome measure.
Time frame: From index date up to hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-avibactam | Duration of Hospital Stay: FAS72+ Population | 36.0 Days |
Primary
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Multi-drug resistance was defined as the isolate being non-susceptible to at least one agent in more than or equal to (\>=) 3 antimicrobial categories, excluding the therapeutic classes to which the pathogen was intrinsically resistant. The number of gram-negative pathogens classified according to the antibiotic resistance to specified antibiotics after treatment initiation were reported in this outcome measure.
Time frame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefuroxime | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor | 4 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor: Ceftazidime/avibactam | 4 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor: Cefoperazone/sulbactam | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor: Ceftolozane/tazobactam | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor: Glycopeptides | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Glycylcycline | 2 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Lipopeptides | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Macrolides | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Monobactam | 9 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Nitroimidazole | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Oxazolidinones | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Penicillins | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors | 21 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Ampicillin-sulbactam | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Amoxicillin-clavulanate | 12 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Piperacillin-tazobactam | 8 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Streptogramins | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Tetracycline | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Other Agents | 5 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Other Agents: Colistin | 4 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Other Agents: Trimethoprim | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Other Agents: Trimethoprim-sulfamethoxazole | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Other Agents: Fosfomycin | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Other Agents: Nitrofurantoin | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Aminoglycosides | 21 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Amphenicol | 2 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Carbapenems | 25 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Carbapenems: Doripenem | 13 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Carbapenems: Ertapenem | 12 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Carbapenems: Imipenem | 20 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Carbapenems: Meropenem | 25 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins | 24 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefalexin | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefazolin | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefepime | 6 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefixime | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefotaxime | 9 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefoxitin | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefpodoxime | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Ceftaroline | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Ceftazidime | 24 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Cephalosporins: Ceftriaxone | 6 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Ticarcillin-clavulanate | 3 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population | Fluoroquinolones | 24 Pathogens |
Primary
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
The number of gram-negative pathogens according to the susceptibility to specific antibiotics after treatment initiation were reported in this outcome measure.
Time frame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Aminoglycosides | 39 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Amphenicol | 2 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Carbapenems | 39 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Carbapenems: Doripenem | 13 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Carbapenems: Ertapenem | 17 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Carbapenems: Imipenem | 31 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Carbapenems: Meropenem | 36 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins | 35 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor: Ceftazidime/avibactam | 5 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor: Cefoperazone/sulbactam | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor: Ceftolozane/tazobactam | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Glycopeptides | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Glycylcycline | 4 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Lipopeptides | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Macrolides | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Monobactam | 9 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Nitroimidazole | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Oxazolidinones | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Penicillins | 2 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors | 30 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Ampicillin-sulbactam | 3 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Amoxicillin-clavulanate | 15 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Piperacillin-tazobactam | 14 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefalexin | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefazolin | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefepime | 12 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefixime | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefotaxime | 13 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefoxitin | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefpodoxime | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Ceftaroline | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Ceftazidime | 27 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Ceftriaxone | 7 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporins: Cefuroxime | 2 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Cephalosporin/beta-lactamase inhibitor | 6 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Penicillins and beta-lactamase inhibitors: Ticarcillin-clavulanate | 3 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Fluoroquinolones | 40 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Streptogramins | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Tetracycline | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Other Agents | 13 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Other Agents: Colistin | 7 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Other Agents: Trimethoprim | 0 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Other Agents: Trimethoprim-sulfamethoxazole | 6 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Other Agents: Fosfomycin | 1 Pathogens |
| Ceftazidime-avibactam | Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population | Other Agents: Nitrofurantoin | 0 Pathogens |
Primary
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
The number of participants classified according to all wards attended during hospitalization were reported in this outcome measure.
Time frame: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population | Surgical | 101 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population | Medical | 195 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population | Onco-hematology | 58 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population | Infectious disease | 27 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population | ICU | 116 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population | Other | 18 Participants |
Primary
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
The number of participants classified according to antibiotics used concurrently with ceftazidime-avibactam were reported in this outcome measure. Participants could have received more than 1 antibiotic.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Carbapenems: Ertapenem | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Carbapenems: Imipenem | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Carbapenems: Meropenem | 28 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Cephalosporins: Ceftazidime | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Glycopeptides: Teicoplanin | 18 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Glycopeptides: Telavancin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Glycopeptides: Vancomycin | 65 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Glycylcycline: Tigecycline | 49 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Lipopeptides: Daptomycin | 21 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Macrolides: Azithromycin | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Macrolides: Clarithromycin | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Macrolides: Clindamycin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Macrolides: Erythromycin | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Macrolides: Fidaxomicin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Monobactam: Aztreonam | 104 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Nitroimidazole: Metronidazole | 60 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Oxazolidinones: Linezolid | 37 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Oxazolidinones: Tedizolid | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins: Amoxicillin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins: Ampicillin | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Fluoroquinolones: Levofloxacin | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Fluoroquinolones: Moxifloxacin | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Other agents | 123 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Polymyxins: Colistin | 60 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Polymyxins: Polymyxin B | 15 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole | 21 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Other antibiotics: Fosfomycin | 12 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Other antibiotics: Isoniazid | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Aminoglycoside: Amikacin | 58 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Aminoglycoside: Gentamicin | 19 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Aminoglycoside: Tobramycin | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Amphenicol: Chloramphenicol | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Carbapenems: Doripenem | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins: Benzylpenicillin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins: Flucloxacillin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins: Ticarcillin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins and beta-lactamase inhibitors: Amoxicillin-clavulanate | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins and beta-lactamase inhibitors: Ampicillin-sulbactam | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Penicillins and beta-lactamase inhibitors: Piperacillin-tazobactam | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Fluoroquinolones: Ciprofloxacin | 15 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Fluoroquinolones: Ofloxacin ear drops | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Tetracycline: Doxycycline | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Other antibiotics: Clofazimine | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Other antibiotics: Ethambutol | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Other antibiotics: Rifampicin | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population | Other antibiotics: Rifaximin | 1 Participants |
Primary
Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population
The number of participants classified according to antibiotics used (Yes or No) for current infection before ceftazidime-avibactam were reported in this outcome measure.
Time frame: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population | Yes | 397 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population | No | 119 Participants |
Primary
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
Number of participants classified according to frequency of dose (once daily \[OD\], every other day \[QOD\], each 48 hours \[h\], continuous infusion per 48 hours \[c/48 h\], three times daily \[TID\], twice daily \[BD\], four times daily \[QID\], one dose, loading dose \[an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose\] etc.,) for ceftazidime-avibactam were reported in this outcome measure.
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 0.75 g*Other: 48 h | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 0.94 g*QOD | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 1.00 g*OD | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 1.00 g*QOD | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 1.00 g*Other: 48 h | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 1.00 g*Other: c/48h | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 1.00 g*TID | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 1.87 g*BD | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 2.00 g*OD | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 2.00 g*QID | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 2.00 g*Other: Loading dose | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 2.00 g*TID | 34 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 2.00 g*BD | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 3.00 g*BD | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72- Population | 2.00 g*Other: one dose | 1 Participants |
Primary
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
Number of participants classified according to frequency of dose (once daily \[OD\], every other day \[QOD\], post-dialysis, each 48 hours \[h\], three times daily \[TID\], twice daily \[BD\], four times daily \[QID\], once loading dose \[an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose\], every three days, once, etc.,) for ceftazidime-avibactam were reported in this outcome measure.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.75 g*BD | 13 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.00 g*QOD | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.00 g*QID | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.00 g*Other: Post dialysis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.00 g*TID | 51 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.00 g*BD | 19 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.20 g*TID | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.25 g*TID | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.50 g*OD | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*OD | 7 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*QID | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*Other: every 3 days | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*Other: once | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*TID | 400 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*BD | 29 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.50 g*OD | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.75 grams (g)*OD | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.75 g*QOD | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.75 g*Other: Post dialysis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.75 g*Other: each 48 h | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.75 g*TID | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.80 g*BD | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 0.94 g*BD | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 1.00 g*OD | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*QOD | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Frequency of Dosing: FAS72+ Population | 2.00 g*Other: Once, loading dose | 2 Participants |
Primary
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
The number of participants classified according to reason for discontinuing for prior antibiotic therapy were reported in this outcome measure. One participant could have more than 1 reason of discontinuation for prior antibiotic therapy.
Time frame: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | AE | 11 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Perceived clinical failure/disease progression | 134 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Isolation of a resistant pathogen | 236 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Preference for empiric coverage | 32 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Secondary infection requiring regimen change | 35 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Switch to oral therapy | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | De-escalation | 58 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Cure | 53 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Death | 11 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population | Other | 69 Participants |
Primary
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | De-escalation | 23 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Adverse events (AEs) | 0 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Isolation of a resistant pathogen | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Secondary infection requiring regimen change | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Switch to oral therapy | 0 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Death | 14 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population | Other | 4 Participants |
Primary
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Adverse events (AEs) | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Perceived clinical failure/disease progression | 10 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Isolation of a resistant pathogen | 9 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Preference for empiric coverage | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Secondary infection requiring regimen change | 11 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | De-escalation | 59 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Cure | 329 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Death | 50 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Switch to oral therapy | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population | Other | 28 Participants |
Primary
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
The number of participants classified according to reason for discontinuing specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for discontinuing antibiotics.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, Number Analyzed signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: Perceived clinical failure/disease progression | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ampicillin: Cure | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ampicillin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ampicillin-sulbactam: De-escalation | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Perceived clinical failure/disease progression | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Isolation of a resistant pathogen | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Other | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ceftazidime: De-escalation | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ceftazidime: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ceftazidime: Death | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ceftazidime: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Chloramphenicol: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: Isolation of a resistant pathogen | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: Switch to oral therapy | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: De-escalation | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ertapenem: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Gentamicin: Isolation of a resistant pathogen | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Gentamicin: Preference for empiric coverage | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: AE | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Perceived clinical failure/disease progression | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Isolation of a resistant pathogen | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Preference for empiric coverage | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Switch to oral therapy | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: De-escalation | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Cure | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Piperacillin-tazobactam: Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Piperacillin-tazobactam: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ticarcillin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: De-escalation | 15 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfa: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: Switch to oral therapy | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: AE | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: Isolation of a resistant pathogen | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tedizolid: Cure | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: AE | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: Isolation of a resistant pathogen | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: Preference for empiric coverage | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: De-escalation | 13 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: Cure | 15 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: Death | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amikacin: Other | 15 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amoxicillin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Amoxicillin-clavulanate: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ampicillin: Switch to oral therapy | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Preference for empiric coverage | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Switch to oral therapy | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: De-escalation | 11 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Cure | 66 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Aztreonam: Death | 11 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: Cure | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ciprofloxacin: Other | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Doripenem: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Gentamicin: De-escalation | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Gentamicin: Cure | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Gentamicin: Other | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Imipenem: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Levofloxacin: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Levofloxacin: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Levofloxacin: De-escalation | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Levofloxacin: Death | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Levofloxacin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Meropenem: Other | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Moxifloxacin: Switch to oral therapy | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Moxifloxacin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Moxifloxacin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Piperacillin-tazobactam: De-escalation | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Piperacillin-tazobactam: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tigecycline: AE | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tigecycline: Perceived clinical failure/disease progression | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tigecycline: Isolation of a resistant pathogen | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tigecycline: De-escalation | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tigecycline: Cure | 23 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tigecycline: Death | 9 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tigecycline: Other | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tobramycin: Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tobramycin: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tobramycin: Cure | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tobramycin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: AE | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Perceived clinical failure/disease progression | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Isolation of a resistant pathogen | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Preference for empiric coverage | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Cure | 19 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Death | 11 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Other | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: Isolation of a resistant pathogen | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: De-escalation | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: Cure | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole (sulfa) : AE | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfa: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Preference for empiric coverage | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: De-escalation | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Cure | 7 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Other | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Fosfomycin: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Fosfomycin: Isolation of a resistant pathogen | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Fosfomycin: De-escalation | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Fosfomycin: Cure | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Fosfomycin: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Rifampicin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Azithromycin: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Azithromycin: Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Azithromycin: Other | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Benzylpenicillin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Clarithromycin: De-escalation | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Clarithromycin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Clindamycin: Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: AE | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: Isolation of a resistant pathogen | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: De-escalation | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: Cure | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Daptomycin: Other | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Doxycycline: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Erythromycin: De-escalation | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Erythromycin: Cure | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Erythromycin: Death | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Erythromycin: Other | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Fidaxomicin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Flucloxacillin: Preference for empiric coverage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: Secondary infection requiring regimen change | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: Switch to oral therapy | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: De-escalation | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: Cure | 18 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Linezolid: Death | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Tedizolid: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Teicoplanin: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Teicoplanin: De-escalation | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Teicoplanin: Cure | 7 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Teicoplanin: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Teicoplanin: Other | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Telavancin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Isolation of a resistant pathogen | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Preference for empiric coverage | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Secondary infection requiring regimen change | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Switch to oral therapy | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: De-escalation | 10 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Cure | 30 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Death | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Vancomycin: Other | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Rifaximin: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Metronidazole: Perceived clinical failure/disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Metronidazole: Preference for empiric coverage | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Metronidazole: De-escalation | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Metronidazole: Cure | 32 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ofloxacin ear drops: Cure | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Metronidazole: Death | 7 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Metronidazole: Other | 11 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Clofazimine: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Ethambutol: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population | Isoniazid: Other | 2 Participants |
Primary
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
The number of participants classified according to reason for initiating specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for initiating antibiotics.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amikacin: Failure of antimicrobial treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amikacin: Infection | 30 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amikacin: Microbiology | 18 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amikacin: Prophylaxis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amoxicillin: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amoxicillin-clavulanate: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ampicillin: Infection | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ampicillin: Microbiology | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ampicillin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ampicillin-sulbactam: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Aztreonam: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Aztreonam: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Aztreonam: Failure of antimicrobial treatment | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Aztreonam: Infection | 23 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Aztreonam: Microbiology | 73 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Aztreonam: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ceftazidime: Infection | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ceftazidime: Microbiology | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Chloramphenicol: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ciprofloxacin: Infection | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Gentamicin: Microbiology | 13 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Meropenem: Infection | 14 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Meropenem: Microbiology | 9 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Meropenem: Prophylaxis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Meropenem: Other | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Moxifloxacin: Infection | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Moxifloxacin: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Piperacillin-tazobactam: Microbiology | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ticarcillin: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tigecycline: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tigecycline: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tigecycline: Failure of antimicrobial treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tigecycline: Infection | 21 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tigecycline: Other | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tobramycin: Infection | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tobramycin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Microbiology | 27 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Other | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Failure of antimicrobial treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Infection | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Prophylaxis | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Other antibiotics: Fosfomycin: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Other antibiotics: Fosfomycin: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Other antibiotics: Fosfomycin: Microbiology | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Other antibiotics: Fosfomycin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Other antibiotics: Rifampicin: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Daptomycin: Other | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Doxycycline: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Linezolid: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Linezolid: Empiric treatment | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Linezolid: Failure of antimicrobial treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Linezolid: Infection | 15 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Linezolid: Microbiology | 13 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tedizolid: Infection | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tedizolid: Microbiology | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Vancomycin: Clostridium difficile | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Vancomycin: Empiric treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Vancomycin: Microbiology | 14 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Vancomycin: Prophylaxis | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Vancomycin: Other | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Other antibiotics: Rifaximin: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Metronidazole: Empiric treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Metronidazole: Failure of antimicrobial treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Metronidazole: Infection | 28 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Metronidazole: Microbiology | 18 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Other antibiotics: Clofazimine: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ethambutol: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Isoniazid: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Isoniazid: Prophylaxis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amikacin: Empiric treatment | 7 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Amikacin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ciprofloxacin: Microbiology | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ciprofloxacin: Prophylaxis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Doripenem: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ertapenem: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Gentamicin: Empiric treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Gentamicin: Infection | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Imipenem: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Levofloxacin: Infection | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Levofloxacin: Microbiology | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Meropenem: Empiric treatment | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Piperacillin-tazobactam: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Piperacillin-tazobactam: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Tigecycline: Microbiology | 20 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Polymyxins: Colistin: Infection | 30 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: Infection | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Polymyxins: Polymyxin B: Microbiology | 9 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Microbiology | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Azithromycin: Infection | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Azithromycin: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Azithromycin: Other | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Benzylpenicillin: Microbiology | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Clarithromycin: Microbiology | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Clindamycin: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Daptomycin: Empiric treatment | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Daptomycin: Infection | 16 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Daptomycin: Microbiology | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Erythromycin: Infection | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Erythromycin: Other | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Fidaxomicin: Clostridium difficile | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Flucloxacillin: Infection | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Teicoplanin: Clostridium difficile | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Teicoplanin: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Teicoplanin: Empiric treatment | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Teicoplanin: Infection | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Teicoplanin: Microbiology | 7 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Teicoplanin: Prophylaxis | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Telavancin: Disease progression | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Vancomycin: Infection | 40 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Metronidazole: Clostridium difficile | 9 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Metronidazole: Prophylaxis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Metronidazole: Other | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population | Ofloxacin ear drops: Infection | 1 Participants |
Primary
Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
The number of participants classified according to the reason for readmission to the hospital were reported in this outcome measure. One participant could have more than 1 reason for readmission to the hospital.
Time frame: At readmission to the hospital, up to maximum of 60 days post initial hospital discharge (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population | Unrelated to the infection | 98 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population | Infection recurrence | 25 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population | Secondary infection | 17 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population | Unknown | 6 Participants |
Primary
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
The number of participants classified according to the healthcare resource utilization during the hospitalization were reported in this outcome measure. One participant could have utilized more than 1 healthcare resource during hospitalization.
Time frame: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | Mechanical ventilation | 161 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | Hemodialysis | 80 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | CT/MRI imaging | 273 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | Tracheostomy | 83 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | Surgical intervention | 169 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | Percutaneous procedures | 149 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population | Other | 73 Participants |
Primary
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
The number of participants classified according to the pathogens identified from the microbiological culture after treatment initiation were reported in this outcome measure.
Time frame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Population: MOD population included all participants with at least 72 hours exposure to ceftazidime-avibactam, identification of one or more pathogens before the start of ceftazidime-avibactam treatment, and at least one non-missing microbiological outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Acinetobacter baumannii | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Enterobacter cloacae | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Enterobacter species (spp) | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Pseudomonas aeruginosa | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Pseudomonas spp | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Other | 8 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-positive: Staphylococcus spp | 6 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-positive: Enterococcus spp | 14 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-positive: Other | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Anaerobes: Clostridium spp | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Other Bacterial Agent | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Escherichia coli | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Klebsiella pneumoniae | 15 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Proteus mirabilis | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Serratia spp | 2 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population | Gram-negative: Morganella morganii | 1 Participants |
Primary
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Time frame: 60 days after hospital discharge (from the data evaluated in approximately 40 months of this study)
Population: COD population included all participants with at least 72 hours exposure to ceftazidime-avibactam and at least one non-missing clinical outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population | Success | 266 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population | Failure | 27 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population | Indeterminate | 24 Participants |
Primary
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Time frame: 60 days post treatment (from the data evaluated in approximately 40 months of this study)
Population: COD population included all participants with at least 72 hours exposure to ceftazidime-avibactam and at least one non-missing clinical outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population | Failure | 32 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population | Indeterminate | 31 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population | Success | 311 Participants |
Primary
Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Time frame: At initial hospitalization (from the data evaluated in approximately 40 months of this study)
Population: COD population included all participants with at least 72 hours exposure to ceftazidime-avibactam and at least one non-missing clinical outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population | Success | 399 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population | Failure | 60 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population | Indeterminate | 57 Participants |
Primary
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
The number of participants classified according to the type of specimen taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure. More than 1 type of specimen could have been taken from 1 participant.
Time frame: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Population: MOD population included all participants with at least 72 hours exposure to ceftazidime-avibactam, identification of one or more pathogens before the start of ceftazidime-avibactam treatment, and at least one non-missing microbiological outcome. Not all participants of MOD population had data collected after end of ceftazidime-avibactam therapy. Hence, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Sputum | 5 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Abscess drainage | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Swab | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Surgical/biopsy specimen | 1 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Blood | 10 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Urine | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Bronchoalveolar lavage | 4 Participants |
| Ceftazidime-avibactam | Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population | Other | 5 Participants |
Primary
Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population
The number of participants readmitted to the hospital during the 30 days after initial discharge were reported in this outcome measure.
Time frame: Up to 30 days after initial discharge (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-avibactam | Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population | 111 Participants |
Primary
Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population
The number of participants readmitted to the hospital during the 60 days after initial discharge were reported in this outcome measure.
Time frame: Up to 60 days after initial discharge (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-avibactam | Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population | 53 Participants |
Primary
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population
Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure. Index date was start date of ceftazidime-avibactam.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population | Combination therapy | 358 Participants |
| Ceftazidime-avibactam | Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population | Monotherapy | 158 Participants |
Primary
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population
Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure.
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population | Monotherapy | 3 Participants |
| Ceftazidime-avibactam | Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population | Combination therapy | 7 Participants |
Primary
Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population
The number of participants whose samples were taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure.
Time frame: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Population: MOD population included all participants with at least 72 hours exposure to ceftazidime-avibactam, identification of one or more pathogens before the start of ceftazidime-avibactam treatment, and at least one non-missing microbiological outcome. Not all participants of MOD population had data collected after end of ceftazidime-avibactam therapy. Hence, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-avibactam | Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population | 20 Participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. AE included both SAEs and non-SAEs. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. Only AEs and SAEs with explicit attribution to ceftazidime-avibactam that appeared in the reviewed information and scenarios involving drug exposure to ceftazidime-avibactam, which included exposure during pregnancy, exposure during breastfeeding, medication error, overdose, misuse, extravasation, lack of efficacy and occupational exposure associated with the use of ceftazidime-avibactam were collected in the study.
Time frame: From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Population: FAS population included all enrolled participants meeting the study eligibility criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-avibactam | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any adverse event | 6 Participants |
| Ceftazidime-avibactam | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious adverse event | 5 Participants |
Primary
Number of Participants With Microbiological Treatment Outcome as Success: MOD Population
The number of participants with microbiological treatment outcome as success were reported in this outcome measure. Success was defined as: absence of causative pathogen from appropriately obtained specimens at the site of infection.
Time frame: Up to 14 days post first dose of ceftazidime-avibactam (from the data evaluated in approximately 40 months of the study)
Population: Planned analysis of this outcome measure was cancelled on approval of Scientific Steering Committee as few participants had microbiological cultures after the start of ceftazidime-avibactam.
Primary
Percentage of Participants Who Died During Index Hospitalization
In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure.
Time frame: During index hospitalization, maximum of 418 days (from the data evaluated in approximately 40 months of this study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-avibactam | Percentage of Participants Who Died During Index Hospitalization | 23.1 Percentage of participants |
Primary
Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
60-day mortality was defined as deaths occurred from index treatment up to within 60 days after hospital discharge including in-hospital mortality.
Time frame: From index treatment up to 60 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-avibactam | Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population | 27.9 Percentage of participants |
Primary
Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
30-day mortality was defined as deaths occurred from index treatment up to within 30 days after hospital discharge including in-hospital mortality.
Time frame: From index treatment up to 30 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-avibactam | Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population | 24.6 Percentage of participants |
Primary
Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population
The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ceftazidime-avibactam | Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population | Total dose | 6.3 Milligrams | Standard Deviation 3.65 |
| Ceftazidime-avibactam | Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population | Daily dose | 4.8 Milligrams | Standard Deviation 1.96 |
Primary
Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population
The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ceftazidime-avibactam | Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population | Total dose | 62.2 Milligram (mg) | Standard Deviation 55.82 |
| Ceftazidime-avibactam | Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population | Daily dose | 5.2 Milligram (mg) | Standard Deviation 1.52 |
Primary
Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population
Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-avibactam | Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population | 1.0 Days |
Primary
Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population
Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-avibactam | Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population | 9.0 Days |
Primary
Total Duration of ICU Stay: FAS72+ Population
Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The total duration of ICU stay of participants were reported in this outcome measure.
Time frame: During index hospitalization, maximum up to 418 days (from the data evaluated in approximately 40 months of the study)
Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-avibactam | Total Duration of ICU Stay: FAS72+ Population | 24.0 Days |