Status:
COMPLETED
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
Lead Sponsor:
Pfizer
Conditions:
Urinary Tract Infection
Acute Pyelonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants wit...
Eligibility Criteria
Inclusion
- Male or female \>18 years of age
- Participant must have a diagnosis of an infection (HAP/VAP, cUTI, cIAI, BSI) due to confirmed carbapenem-resistant aerobic Gram-negative pathogens, requiring administration of IV antibacterial therapy
- Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy.
- Capable of giving signed informed consent
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 more than 21 days of treatment
- Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
- 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).
- Participant is pregnant or breastfeeding.
- Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30 or \<10 using the most recent available data.
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04882085
Start Date
August 26 2021
End Date
August 31 2023
Last Update
October 21 2024
Active Locations (37)
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1
The First Affiliated Hospital of Bengbu Medical
Bengbu, Anhui, China, 233000
2
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
3
Chizhou People's Hospital
Chizhou, Anhui, China, 247000
4
Fuyang People's Hospital
Fuyang, Anhui, China, 236000