Phase 4
N=235
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
Hospital-Acquired Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04774094 ↗Enrolled (actual)
235
Serious AEs
14.9%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population — 62.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zavicefta, Ceftazidime-Avibactam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population |
62.7 | — |
| SECONDARY Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population |
75.1 | — |
| SECONDARY Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population |
70.0; 57.5 | — |
| SECONDARY Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population |
77.5; 51.3 | — |
| SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population |
33.3; 100; 80.0; 77.6; 100; 100 | — |
| SECONDARY Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population |
63.3; 53.3 | — |
| SECONDARY Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population |
73.3; 46.7 | — |
| SECONDARY Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population |
5.7; 5.7 | — |
| SECONDARY Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population |
7.5; 7.5 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
204 | — |
| SECONDARY Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities |
102 | — |
| SECONDARY Number of Participants With Vital Signs Data According to Pre-defined Criteria |
18; 72; 54; 1; 31; 11 | — |
Summary
This is a prospective, single arm, open-label, multi-center clinical study evaluating the effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI in the hospital for at least 7 full days. There are no formal hypothesis tests planned for this study. The number and percent of participants having clinical cure, failure, and indeterminate at TOC visit in the cMITT analysis population will be summarized.
Eligibility Criteria
Inclusion Criteria
- Male or female participants ≥18 and ≤90 years of age.
- Onset of symptoms ≥48 hours after admission or 30 or <10 using the most recent available data.
Data sourced from ClinicalTrials.gov (NCT04774094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.