Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
Recruiting now · Phase 4
Conditions studied: Carbapenem Resistant Bacterial Infection, Acinetobacter Bacteremia, Acinetobacter Pneumonia
In brief
Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.
Key facts
- Study ID
- NCT05922124
- Run by
- Rambam Health Care Campus
- People needed
- 734
- Starts
- 2024-09-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-08-01
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults >18 years with bacteremia or hospital-acquired pneumonia (HAP)/ ventilator-associated pneumonia (VAP) (Table 3) caused by carbapenem-resistant A. baumannii (CRAB) (meropenem and/ or imipenem minimal inhibitory concentration (MIC) >8 μg/mL) susceptible to cefiderocol (disc zone diameter >=17 mm, corresponding to an MIC <2 μg/mL). We will include CRAB regardless of colistin, ampicillin-sulbactam, minocycline, tigecycline, trimethoprim/sulfamethoxazole and/or aminoglycoside susceptibility of the isolate. Attribution of the HAP/ VAP to CRAB will be allowed with isolation of CRAB from any respiratory sample within 7 days prior to the clinical diagnosis of pneumonia.
You may not qualify if…
- More than 72 hours of therapy with in-vitro coverage against the CRAB within 96 hours of enrolment
- Polymicrobial carbapenem-susceptible infections: growth of other pathogens susceptible to carbapenems, or another beta-lactam, deemed clinically-significant by the treating physicians in blood or sputum (with HAP/ VAP). We will allow recruitment of patients with other carbapenem-resistant Gram-negative bacteria
- CRAB susceptible any beta-lactam other than cefiderocol
- Coronavirus 2019 (COVID-19) co-infection
- Immediate-type hypersensitivity to penicillin
- Pregnant women
- Previous participation in the trial
- Lack of informed consent, considering the procedures acceptable to ethics committees per locale, including deferred consent
- Infection requiring treatment for over 14 days, at the discretion of the investigators
- Life expectancy less than 24 hours or expected futility of antibiotic treatment
Where it is running
- Rambam Health Care Campus — Haifa, Israel (enrolling)
- Sheba Tel HaShomer Medical Campus — Ramat Gan, Israel (enrolling)
- Shamir Medical Center (Assaf Harofeh) — Tel Aviv, Israel (enrolling)
Full record on ClinicalTrials.gov
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