Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)

  • STATUS
    Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    235
  • sponsor
    Pfizer
Updated on 11 May 2022

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.

Details
Condition Hospital-Acquired Pneumonia
Treatment Zavicefta, Ceftazidime-Avibactam
Clinical Study IdentifierNCT04774094
SponsorPfizer
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants ≥18 and ≤90 years of age
Onset of symptoms ≥48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility
New or worsening infiltrate on chest X-ray obtained within 48 hours prior to screening
Participants have systemic signs and respiratory signs or symptoms of HAP/VAP

Exclusion Criteria

Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
Participant is expected to require a treatment course for HAP longer than 14 days
The total duration of antibiotic exposure for antibiotics whose administration begins in the 48 hours is longer than 24 hours
Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer)
Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 or <10 using the most recent available data
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