Status:
TERMINATED
Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Conditions:
Carbapenem-Resistant Enterobacteriaceae Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05258851
Start Date
June 1 2022
End Date
January 28 2024
Last Update
June 14 2024
Active Locations (1)
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1
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia