Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections (AVI-ICU)

  • STATUS
    Recruiting
  • End date
    Aug 30, 2023
  • participants needed
    168
  • sponsor
    King Faisal Specialist Hospital & Research Center
Updated on 14 July 2022

Summary

Carbapenem-Resistant Enterobacteriaceae (CRE) infections are a growing national and international challenge in healthcare settings. This is not only due to the rapid spread of resistance and paucity of options of targeted-antimicrobial agents, but also owing to the high mortality of patients infected with CRE reaching up to 50% as per the Centers of Disease Control and Prevention.

Colistin-based combination regimens have been the mainstay for treating CRE-related infections. Ceftazidime-avibactam is a beta-lactamase inhibitor combination, a novel antibiotic, which recently showed a better clinical and microbiological cure against CRE along with the potential to reduce mortality and nephrotoxicity in comparison to colistin-based regimens in observational studies. However, randomized clinical trials are lacking.

This non-inferiority randomized controlled study aims to assess the efficacy and safety of ceftazidime-avibactam-based regimens in critically ill patients with CRE infections in comparison to colistin-based regimens.

Details
Condition Carbapenem-Resistant Enterobacteriaceae Infection
Treatment Colistin, Ceftazidime-avibactam
Clinical Study IdentifierNCT05258851
SponsorKing Faisal Specialist Hospital & Research Center
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged ≥ 18 years
Admitted to an intensive care unit (ICU)
Patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI), bacteremia, complicated intraabdominal infection (cIAI), and complicated skin and soft tissue infection (cSSTI)
Confirmed infection with CRE, based on a culture and sensitivity obtained within the past 72 hours of study enrollment
Suspected CRE infection according to one of the following: (1) positive Xpert Carba-R test screening for blaKPC or blaOXA-48 or blaNDM or blaVIM or blaIMI assessed on the admission to the ICU, (2) positive culture for CRE obtained within 3 months from time of enrollment

Exclusion Criteria

Acute Physiology and Chronic Health Evaluation II (APACHE II) score more than 30
known significant hypersensitivity reaction to beta-lactam antibiotics or colistin
Positive culture for Stenotrophomonas maltophilia or Acinetobacter baumannii within the current hospitalization
Patients received the study intervention or control for more than 24 hours before the intended randomization
Patient/substitute decision-maker or caring physician's refusal to enroll in the study
Patient with concomitant suspected or confirmed meningitis
Pregnancy
Cystic fibrosis
Patients with Do Not Attempt to Resuscitate (DNAR) code status
Prior knowledge that the index CRE pathogen was resistant to colistin (MIC >2 μg/ml) or ceftazidime-avibactam (MIC > 8 μg/ml) before randomization
Objective clinical evidence for any of the following infections that necessitate study therapy for >14 days: endovascular infection, including endocarditis, osteomyelitis, prosthetic joint infection, meningitis, and/or other central nervous system infections
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