Status:
COMPLETED
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
Lead Sponsor:
Pfizer
Conditions:
Hospital-Acquired Pneumonia
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT04774094
Start Date
May 21 2021
End Date
May 4 2023
Last Update
September 19 2024
Active Locations (56)
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1
Fuyang People's Hospital
Fuyang, Anhui, China, 236000
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
4
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004