Trials / Completed
CompletedNCT04774094
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 235 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zavicefta, Ceftazidime-Avibactam | 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. |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2023-05-04
- Completion
- 2023-05-04
- First posted
- 2021-03-01
- Last updated
- 2024-09-19
- Results posted
- 2024-09-19
Locations
56 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04774094. Inclusion in this directory is not an endorsement.