Trial Outcomes & Findings for Real-World Study of Ceftazidime Avibactam in China (NCT NCT05487586)
NCT ID: NCT05487586
Last Updated: 2025-09-04
Results Overview
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.
TERMINATED
220 participants
Day 7 (from the data evaluated in approximately 21 months of the study)
2025-09-04
Participant Flow
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.
Data was abstracted from medical records and evaluated over approximately 21 months of this study.
Participant milestones
| Measure |
Ceftazidime-Avibactam
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Overall Study
STARTED
|
220
|
|
Overall Study
COMPLETED
|
192
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Ceftazidime-Avibactam
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Overall Study
Death
|
22
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Transfer to another hospital
|
4
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Age, Continuous
|
62.4 Years
STANDARD_DEVIATION 16.73 • n=220 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=220 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=220 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=153 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Clinical Success Rate at Day 7
|
37.3 Percentage of Participants
Interval 29.6 to 45.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=125 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Clinical Success Rate at Day 14
|
44.8 Percentage of Participants
Interval 35.9 to 54.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=94 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Clinical Success Rate at Day 21
|
46.8 Percentage of Participants
Interval 36.4 to 57.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=69 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Clinical Success Rate at Day 30
|
43.5 Percentage of Participants
Interval 31.6 to 56.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=29 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Clinical Success Rate at Day 60
|
69.0 Percentage of Participants
Interval 49.2 to 84.7
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Clinical Success Rate at End of Treatment (EOT)
|
66.4 Percentage of Participants
Interval 59.6 to 72.7
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=146 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7
|
43.2 Percentage of Participants
Interval 35.0 to 51.6
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=118 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14
|
50.0 Percentage of Participants
Interval 40.7 to 59.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=85 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21
|
49.4 Percentage of Participants
Interval 38.4 to 60.5
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=63 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30
|
52.4 Percentage of Participants
Interval 39.4 to 65.1
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=28 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60
|
64.3 Percentage of Participants
Interval 44.1 to 81.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=202 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT
|
69.8 Percentage of Participants
Interval 63.0 to 76.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=165 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7
|
46.1 Percentage of Participants
Interval 38.3 to 54.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=126 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14
|
50.0 Percentage of Participants
Interval 41.0 to 59.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=90 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21
|
54.4 Percentage of Participants
Interval 43.6 to 65.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=69 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30
|
49.3 Percentage of Participants
Interval 37.0 to 61.6
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=29 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60
|
65.5 Percentage of Participants
Interval 45.7 to 82.1
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=207 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT
|
69.6 Percentage of Participants
Interval 62.8 to 75.8
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=111 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7
Klebsiella pneumoniae
|
43.5 Percentage of Participants
Interval 32.8 to 54.7
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7
Pseudomonas aeruginosa
|
38.5 Percentage of Participants
Interval 20.2 to 59.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=90 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14
Klebsiella pneumoniae
|
40.8 Percentage of Participants
Interval 29.3 to 53.2
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14
Pseudomonas aeruginosa
|
42.1 Percentage of Participants
Interval 20.3 to 66.5
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=62 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21
Klebsiella pneumoniae
|
46.0 Percentage of Participants
Interval 31.8 to 60.7
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21
Pseudomonas aeruginosa
|
50.0 Percentage of Participants
Interval 21.1 to 78.9
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=43 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30
Klebsiella pneumoniae
|
40.0 Percentage of Participants
Interval 23.9 to 57.9
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30
Pseudomonas aeruginosa
|
50.0 Percentage of Participants
Interval 15.7 to 84.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=23 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60
Klebsiella pneumoniae
|
66.7 Percentage of Participants
Interval 41.0 to 86.7
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60
Pseudomonas aeruginosa
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=141 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT
Klebsiella pneumoniae
|
65.5 Percentage of Participants
Interval 55.8 to 74.3
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT
Pseudomonas aeruginosa
|
64.5 Percentage of Participants
Interval 45.4 to 80.8
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=64 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7
Klebsiella pneumoniae
|
44.4 Percentage of Participants
Interval 30.9 to 58.6
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7
Pseudomonas aeruginosa
|
50.0 Percentage of Participants
Interval 18.7 to 81.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=50 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14
Klebsiella pneumoniae
|
29.3 Percentage of Participants
Interval 16.1 to 45.5
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14
Pseudomonas aeruginosa
|
55.6 Percentage of Participants
Interval 21.2 to 86.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=35 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21
Pseudomonas aeruginosa
|
80.0 Percentage of Participants
Interval 28.4 to 99.5
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21
Klebsiella pneumoniae
|
46.7 Percentage of Participants
Interval 28.3 to 65.7
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=31 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30
Klebsiella pneumoniae
|
30.8 Percentage of Participants
Interval 14.3 to 51.8
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30
Pseudomonas aeruginosa
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=15 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60
Klebsiella pneumoniae
|
46.2 Percentage of Participants
Interval 19.2 to 74.9
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60
Pseudomonas aeruginosa
|
100.0 Percentage of Participants
Interval 15.8 to 100.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=74 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT
Klebsiella pneumoniae
|
64.5 Percentage of Participants
Interval 51.3 to 76.3
|
|
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT
Pseudomonas aeruginosa
|
66.7 Percentage of Participants
Interval 34.9 to 90.1
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=215 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date
Complicated intra-abdominal infections (cIAI)
|
37 Participants
|
|
Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date
Hospital-acquired pneumonia/ Ventilator-associated pneumonia (HAP/VAP)
|
129 Participants
|
|
Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date
Limited treatment options (LTO)
|
49 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=174 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Source of Infection
Hospital-acquired infection (HAI)
|
134 Participants
|
|
Number of Participants According to Source of Infection
Community-acquired infection (CAI)
|
40 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=227 Strains
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Isolated Strains
Pseudomonas aeruginosa
|
33 Strains
|
|
Number of Isolated Strains
Klebsiella pneumoniae
|
129 Strains
|
|
Number of Isolated Strains
Serratia marcescens
|
5 Strains
|
|
Number of Isolated Strains
Enterobacter cloacae
|
4 Strains
|
|
Number of Isolated Strains
Escherichia coli
|
4 Strains
|
|
Number of Isolated Strains
Proteus mirabilis
|
3 Strains
|
|
Number of Isolated Strains
Klebsiella oxytoca
|
1 Strains
|
|
Number of Isolated Strains
Other
|
48 Strains
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=162 Strains
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Klebsiella pneumoniae: Meropenem
|
101 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Klebsiella pneumoniae: Imipenem
|
58 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Klebsiella pneumoniae: Tigecycline
|
6 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Klebsiella pneumoniae: Ceftazidime-Avibactam
|
5 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Klebsiella pneumoniae: Polymyxins
|
12 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Klebsiella pneumoniae: Polymyxin B
|
3 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Pseudomonas aeruginosa: Meropenem
|
18 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Pseudomonas aeruginosa: Imipenem
|
13 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Pseudomonas aeruginosa: Polymyxins
|
0 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Pseudomonas aeruginosa: Polymyxin B
|
0 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Pseudomonas aeruginosa: Tigecycline
|
2 Strains
|
|
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Pseudomonas aeruginosa: Ceftazidime-Avibactam
|
1 Strains
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=160 Strains
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Carbapenem-Resistant Strains
Klebsiella pneumoniae
|
108 Strains
|
|
Number of Carbapenem-Resistant Strains
Pseudomonas aeruginosa
|
25 Strains
|
|
Number of Carbapenem-Resistant Strains
Enterobacter cloacae
|
2 Strains
|
|
Number of Carbapenem-Resistant Strains
Serratia marcescens
|
3 Strains
|
|
Number of Carbapenem-Resistant Strains
Escherichia coli
|
4 Strains
|
|
Number of Carbapenem-Resistant Strains
Other
|
18 Strains
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
2.5 grams: TID
|
178 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
2.5 grams: BID
|
18 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
2.5 grams: QD
|
8 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
2.5 grams: Other
|
10 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
1.25 grams: TID
|
15 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
1.25 grams: BID
|
7 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
1.25 grams: QD
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
0.94 grams: QD
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
3 grams: BID
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
1.25 grams: Other
|
2 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
1 gram: BID
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
2 grams: TID
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
2.5 grams: TID
|
173 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
2.5 grams: BID
|
17 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
2.5 grams: QD
|
8 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
2.5 grams: Other
|
10 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
1.25 grams: TID
|
15 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
1.25 grams: BID
|
7 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
1.25 grams: QD
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
1.25 grams: Other
|
2 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
0.94 grams: QD
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
1 gram: BID
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
2 grams: TID
|
1 Participants
|
|
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
3 grams: BID
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set
|
12.0 Days
Interval 2.0 to 86.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
|
12.0 Days
Interval 3.0 to 86.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set
|
176 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
|
172 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Hospital Length of Stay (LOS): Full Analysis Set
|
36.5 Days
Interval 4.0 to 751.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Hospital Length of Stay (LOS): CE Analysis Set
|
36.0 Days
Interval 6.0 to 751.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=99 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Intensive Care Unit (ICU) LOS: Full Analysis Set
|
25.0 Days
Interval 1.0 to 751.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=95 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
ICU LOS: Clinically Evaluable Analysis Set
|
25.0 Days
Interval 1.0 to 751.0
|
SECONDARY outcome
Timeframe: 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.
The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set
Pneumonia
|
31 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set
Respiratory failure
|
29 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set
Hypertension
|
24 Participants
|
SECONDARY outcome
Timeframe: 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.
The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set
Pneumonia
|
31 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set
Respiratory failure
|
29 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set
Hypertension
|
23 Participants
|
SECONDARY outcome
Timeframe: 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.
The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set
Pneumonia
|
121 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set
Septic shock
|
42 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set
Sepsis
|
39 Participants
|
SECONDARY outcome
Timeframe: 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.
The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set
Pneumonia
|
120 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set
Septic shock
|
42 Participants
|
|
Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set
Sepsis
|
39 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set
|
193 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set
|
187 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=72 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Duration of Mechanical Ventilation: Full Analysis Set
|
17.0 Days
Interval 1.0 to 128.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=71 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set
|
17.0 Days
Interval 1.0 to 128.0
|
SECONDARY outcome
Timeframe: 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.
95% CI was based on Clopper-Pearson method.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
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
Interval 6.0 to 15.0
|
|
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
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 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.
95% CI was based on Clopper-Pearson method.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
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
Interval 7.0 to 15.0
|
|
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
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=220 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Percentage of Participants Who Died During Hospitalization: Full Analysis Set
|
10 Percentage of Participants
Interval 6.0 to 15.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Ceftazidime-Avibactam
n=214 Participants
Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study.
|
|---|---|
|
Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set
|
10 Percentage of Participants
Interval 6.0 to 15.0
|
Adverse Events
Ceftazidime-Avibactam
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER