Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae… (NCT05258851) | Clinical Trial Compass
TerminatedPhase 3
Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections
Stopped: Difficulties encountered in the recruitment process and slow enrollment. The study was not terminated due to any safety issues or concerns.
Saudi Arabia29 participantsStarted 2022-06-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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.
What they're measuring
1
28-day mortality
Timeframe: 28 days from randomization
Trial details
NCT IDNCT05258851
SponsorKing Faisal Specialist Hospital & Research Center