Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    60
  • sponsor
    Pfizer
Updated on 24 May 2022
pneumonia
fosfomycin
carbapenem
antibacterial
ceftazidime
meropenem
bloodstream infection
abdominal infection
ceftazidime-avibactam
amikacin

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 with selected infection types (Hospital Acquired Pneumonia [HAP] (including Ventilator-Associated Pneumonia [VAP]); Complicated Urinary-Tract Infection [cUTI]; Complicated Intra-Abdominal Infection [cIAI]; Bloodstream Infection [BSI]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.

Details
Condition Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia, Bacteremia, Intra-abdominal Infection
Treatment Zavicefta, Ceftazidime-Avibactam, Best Available Treatment
Clinical Study IdentifierNCT04882085
SponsorPfizer
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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