Complicated Intra Abdominal Infections, Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia
Conditions
Keywords
hospital acquired pneumonia, ventilator acquired pneumonia, complicated intra abdominal infections, ceftazidime avibactam, carbapenem-resistant Enterobacteriaceae
Brief summary
This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.
Detailed description
The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.
Interventions
DRUGceftazidime avibactam group
Non-Interventional Study
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
： * Initiate ≥1 dose of ceftazidime-avibactam during hospitalization. * Aged ≥ 18 years old at the time of the informed consent signature. * Provide signed informed consent.
Exclusion criteria
： * Are enrolled in any clinical trial, including enrollment in non interventional studies. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Carbapenem-Resistant Strains | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) | The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60 | Day 60 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7 | Day 7 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14 | Day 14 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21 | Day 21 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30 | Day 30 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60 | Day 60 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7 | Day 7 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14 | Day 14 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21 | Day 21 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30 | Day 30 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60 | Day 60 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7 | Day 7 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14 | Day 14 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21 | Day 21 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30 | Day 30 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60 | Day 60 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date | At index date (from the data evaluated in approximately 21 months of the study) | Index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria. |
| Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) | The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participant's first hospitalization met the eligible criteria. Number of strains with resistance to ceftazidime-avibactam and other antibiotic drugs is reported. One strain could be resistant to more than one antibiotic. |
| Clinical Success Rate at Day 7 | Day 7 (from the data evaluated in approximately 21 months of the study) | The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. |
| Clinical Success Rate at Day 14 | Day 14 (from the data evaluated in approximately 21 months of the study) | The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. |
| Clinical Success Rate at Day 21 | Day 21 (from the data evaluated in approximately 21 months of the study) | The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. |
| Clinical Success Rate at Day 30 | Day 30 (from the data evaluated in approximately 21 months of the study) | The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. |
| Clinical Success Rate at Day 60 | Day 60 (from the data evaluated in approximately 21 months of the study) | The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. |
| Clinical Success Rate at End of Treatment (EOT) | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7 | Day 7 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (gram positive/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Number of Participants According to Source of Infection | At index date (from the data evaluated in approximately 21 months of the study) | Index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria. |
| Number of Isolated Strains | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) | The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14 | Day 14 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21 | Day 21 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30 | Day 30 (from the data evaluated in approximately 21 months of the study) | The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once. |
| Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods. |
| Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods. |
| Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | — |
| Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | — |
| Hospital Length of Stay (LOS): Full Analysis Set | From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study) | Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Hospital Length of Stay (LOS): CE Analysis Set | From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study) | Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Intensive Care Unit (ICU) LOS: Full Analysis Set | During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study) | Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| ICU LOS: Clinically Evaluable Analysis Set | During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study) | Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set | At admission to the hospital (from the data evaluated in approximately 21 months of the study) | The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure. |
| Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set | At admission to the hospital (from the data evaluated in approximately 21 months of the study) | The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure. |
| Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set | At discharge from the hospital (from the data evaluated in approximately 21 months of the study) | The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure. |
| Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set | At discharge from the hospital (from the data evaluated in approximately 21 months of the study) | The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure. |
| Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) | The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) | The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Duration of Mechanical Ventilation: Full Analysis Set | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) | For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) | For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. |
| Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set | Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study) | 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set | Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study) | 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants Who Died During Hospitalization: Full Analysis Set | During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the 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. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set | During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the 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. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method. |
| Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) | Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once. |
Countries
China
Participant flow
Recruitment details
Participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled. Participants were recruited across 15 clinical research centers in China and were followed from first dose of ceftazidime-avibactam until death, withdrawal from study or 60 days post hospital discharge, whichever occurred first. Participants who initiated treatment with \>=1 dose of ceftazidime-avibactam from 01 July 2022 to 31 December 2022 (index period of 6 months) were enrolled.
Pre-assignment details
Data was abstracted from medical records and evaluated over approximately 21 months of this study.
Participants by arm
| Arm | Count |
|---|---|
| Ceftazidime-Avibactam Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study. | 220 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 22 |
| Overall Study | Other | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Transfer to another hospital | 4 |
Baseline characteristics
| Characteristic | Ceftazidime-Avibactam | — |
|---|---|---|
| Age, Continuous | 62.4 Years STANDARD_DEVIATION 16.73 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 70 Participants | — |
| Sex: Female, Male Male | 150 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 220 |
| other Total, other adverse events | 0 / 220 |
| serious Total, serious adverse events | 0 / 220 |
Outcome results
Primary
Clinical Success Rate at Day 14
The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Clinical Success Rate at Day 14 | 44.8 Percentage of Participants |
Primary
Clinical Success Rate at Day 21
The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Clinical Success Rate at Day 21 | 46.8 Percentage of Participants |
Primary
Clinical Success Rate at Day 30
The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Clinical Success Rate at Day 30 | 43.5 Percentage of Participants |
Primary
Clinical Success Rate at Day 60
The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Clinical Success Rate at Day 60 | 69.0 Percentage of Participants |
Primary
Clinical Success Rate at Day 7
The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
Population: The clinically evaluable (CE) analysis set included all participants from the full analysis set (FAS) with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Clinical Success Rate at Day 7 | 37.3 Percentage of Participants |
Primary
Clinical Success Rate at End of Treatment (EOT)
The clinical success rate was defined as the number of participants with clinical outcome as success in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Clinical Success Rate at End of Treatment (EOT) | 66.4 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14 | 50.0 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21 | 54.4 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30 | 49.3 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60 | 65.5 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7 | 46.1 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT | 69.6 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14 | 50.0 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21 | 49.4 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30 | 52.4 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60 | 64.3 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (gram positive/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
Population: The microbiologically evaluable (ME) analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7 | 43.2 Percentage of Participants |
Primary
Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT | 69.8 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14 | Klebsiella pneumoniae | 29.3 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14 | Pseudomonas aeruginosa | 55.6 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21 | Klebsiella pneumoniae | 46.7 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21 | Pseudomonas aeruginosa | 80.0 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30 | Klebsiella pneumoniae | 30.8 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30 | Pseudomonas aeruginosa | 40.0 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60 | Klebsiella pneumoniae | 46.2 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60 | Pseudomonas aeruginosa | 100.0 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7 | Klebsiella pneumoniae | 44.4 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7 | Pseudomonas aeruginosa | 50.0 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT | Klebsiella pneumoniae | 64.5 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT | Pseudomonas aeruginosa | 66.7 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14 | Klebsiella pneumoniae | 40.8 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14 | Pseudomonas aeruginosa | 42.1 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21 | Klebsiella pneumoniae | 46.0 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21 | Pseudomonas aeruginosa | 50.0 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30 | Klebsiella pneumoniae | 40.0 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30 | Pseudomonas aeruginosa | 50.0 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60 | Klebsiella pneumoniae | 66.7 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60 | Pseudomonas aeruginosa | 40.0 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7 | Klebsiella pneumoniae | 43.5 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7 | Pseudomonas aeruginosa | 38.5 Percentage of Participants |
Primary
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome success in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT | Klebsiella pneumoniae | 65.5 Percentage of Participants |
| Ceftazidime-Avibactam | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT | Pseudomonas aeruginosa | 64.5 Percentage of Participants |
Primary
Number of Carbapenem-Resistant Strains
The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Carbapenem-Resistant Strains | Klebsiella pneumoniae | 108 Strains |
| Ceftazidime-Avibactam | Number of Carbapenem-Resistant Strains | Pseudomonas aeruginosa | 25 Strains |
| Ceftazidime-Avibactam | Number of Carbapenem-Resistant Strains | Enterobacter cloacae | 2 Strains |
| Ceftazidime-Avibactam | Number of Carbapenem-Resistant Strains | Serratia marcescens | 3 Strains |
| Ceftazidime-Avibactam | Number of Carbapenem-Resistant Strains | Escherichia coli | 4 Strains |
| Ceftazidime-Avibactam | Number of Carbapenem-Resistant Strains | Other | 18 Strains |
Primary
Number of Isolated Strains
The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Units Analyzed'' signifies number of strains evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Isolated Strains | Klebsiella oxytoca | 1 Strains |
| Ceftazidime-Avibactam | Number of Isolated Strains | Pseudomonas aeruginosa | 33 Strains |
| Ceftazidime-Avibactam | Number of Isolated Strains | Klebsiella pneumoniae | 129 Strains |
| Ceftazidime-Avibactam | Number of Isolated Strains | Serratia marcescens | 5 Strains |
| Ceftazidime-Avibactam | Number of Isolated Strains | Enterobacter cloacae | 4 Strains |
| Ceftazidime-Avibactam | Number of Isolated Strains | Escherichia coli | 4 Strains |
| Ceftazidime-Avibactam | Number of Isolated Strains | Proteus mirabilis | 3 Strains |
| Ceftazidime-Avibactam | Number of Isolated Strains | Other | 48 Strains |
Primary
Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date
Index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.
Time frame: At index date (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date | Complicated intra-abdominal infections (cIAI) | 37 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date | Hospital-acquired pneumonia/ Ventilator-associated pneumonia (HAP/VAP) | 129 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date | Limited treatment options (LTO) | 49 Participants |
Primary
Number of Participants According to Source of Infection
Index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.
Time frame: At index date (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Source of Infection | Hospital-acquired infection (HAI) | 134 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Source of Infection | Community-acquired infection (CAI) | 40 Participants |
Primary
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participant's first hospitalization met the eligible criteria. Number of strains with resistance to ceftazidime-avibactam and other antibiotic drugs is reported. One strain could be resistant to more than one antibiotic.
Time frame: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Klebsiella pneumoniae: Polymyxin B | 3 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Klebsiella pneumoniae: Meropenem | 101 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Klebsiella pneumoniae: Imipenem | 58 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Klebsiella pneumoniae: Tigecycline | 6 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Klebsiella pneumoniae: Ceftazidime-Avibactam | 5 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Klebsiella pneumoniae: Polymyxins | 12 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Pseudomonas aeruginosa: Meropenem | 18 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Pseudomonas aeruginosa: Imipenem | 13 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Pseudomonas aeruginosa: Tigecycline | 2 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Pseudomonas aeruginosa: Ceftazidime-Avibactam | 1 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Pseudomonas aeruginosa: Polymyxins | 0 Strains |
| Ceftazidime-Avibactam | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | Pseudomonas aeruginosa: Polymyxin B | 0 Strains |
Secondary
Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods.
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 12.0 Days |
Secondary
Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set
For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods.
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set | 12.0 Days |
Secondary
Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set
For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set | 17.0 Days |
Secondary
Duration of Mechanical Ventilation: Full Analysis Set
For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Duration of Mechanical Ventilation: Full Analysis Set | 17.0 Days |
Secondary
Hospital Length of Stay (LOS): CE Analysis Set
Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Hospital Length of Stay (LOS): CE Analysis Set | 36.0 Days |
Secondary
Hospital Length of Stay (LOS): Full Analysis Set
Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Hospital Length of Stay (LOS): Full Analysis Set | 36.5 Days |
Secondary
ICU LOS: Clinically Evaluable Analysis Set
Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | ICU LOS: Clinically Evaluable Analysis Set | 25.0 Days |
Secondary
Intensive Care Unit (ICU) LOS: Full Analysis Set
Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Intensive Care Unit (ICU) LOS: Full Analysis Set | 25.0 Days |
Secondary
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once.
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Number Analyzed'' signifies participants evaluable for the specified dosage. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 2.5 grams: TID | 173 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 2.5 grams: BID | 17 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 2.5 grams: QD | 8 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 2.5 grams: Other | 10 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 1.25 grams: TID | 15 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 1.25 grams: BID | 7 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 1.25 grams: QD | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 1.25 grams: Other | 2 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 0.94 grams: QD | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 1 gram: BID | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 2 grams: TID | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 3 grams: BID | 1 Participants |
Secondary
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once.
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Number Analyzed'' signifies participants evaluable for the specified dosage. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 2.5 grams: TID | 178 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 2.5 grams: BID | 18 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 2.5 grams: QD | 8 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 2.5 grams: Other | 10 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 1.25 grams: TID | 15 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 1.25 grams: BID | 7 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 1.25 grams: QD | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 1.25 grams: Other | 2 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 0.94 grams: QD | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 1 gram: BID | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 2 grams: TID | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | 3 grams: BID | 1 Participants |
Secondary
Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set
The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure.
Time frame: At admission to the hospital (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set | Pneumonia | 31 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set | Respiratory failure | 29 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set | Hypertension | 23 Participants |
Secondary
Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set
The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure.
Time frame: At admission to the hospital (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set | Pneumonia | 31 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set | Respiratory failure | 29 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set | Hypertension | 24 Participants |
Secondary
Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set
The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure.
Time frame: At discharge from the hospital (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set | Pneumonia | 120 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set | Septic shock | 42 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set | Sepsis | 39 Participants |
Secondary
Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set
The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure.
Time frame: At discharge from the hospital (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set | Pneumonia | 121 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set | Septic shock | 42 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set | Sepsis | 39 Participants |
Secondary
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | 172 Participants |
Secondary
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set | 176 Participants |
Secondary
Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set
The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set | 187 Participants |
Secondary
Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set
The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set | 193 Participants |
Secondary
Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set
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. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method.
Time frame: During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set | 10 Percentage of Participants |
Secondary
Percentage of Participants Who Died During Hospitalization: Full Analysis Set
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. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method.
Time frame: During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftazidime-Avibactam | Percentage of Participants Who Died During Hospitalization: Full Analysis Set | 10 Percentage of Participants |
Secondary
Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set
95% CI was based on Clopper-Pearson method.
Time frame: Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study)
Population: The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set | Within 30 days after discharge | 10 Percentage of Participants |
| Ceftazidime-Avibactam | Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set | Within 31-60 days after discharge | 3 Percentage of Participants |
Secondary
Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set
95% CI was based on Clopper-Pearson method.
Time frame: Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study)
Population: The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam | Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set | Within 30 days after discharge | 10 Percentage of Participants |
| Ceftazidime-Avibactam | Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set | Within 31-60 days after discharge | 3 Percentage of Participants |