CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 235 enrolled
Drug / intervention
Zavicefta, Ceftazidime-Avibactamdrug
Likely dose
Zavicefta, Ceftazidime-Avibactam 2000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04774094
NCT04774094Phase 4Completed
CompareCT.gov

A SINGLE ARM, OPEN-LABEL, MULTI-CENTER, INTERVENTIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHINESE ADULTS WITH HAP (INCLUDING VAP)

Pfizer·interventional·Posted Mar 1, 2021·Updated Sep 19, 2024

In Brief

A Phase 4 clinical trial evaluating Zavicefta, Ceftazidime-Avibactam for Hospital-Acquired Pneumonia. Completed, enrolled 235 participants across 56 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHospital-Acquired Pneumonia
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 1, 2021
Enrollment StartMay 21, 2021
Primary CompletionMay 4, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.3 years ago

Interventions

Zavicefta, Ceftazidime-Avibactamdrug

Participants will receive CAZ-AVI (2000 mg of ceftazidime and 500 mg of avibactam) administered by IV infusion in a volume of 100 mL at a constant rate over 2 hours.