Actively Recruiting
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
Led by Rambam Health Care Campus · Updated on 2025-08-01
734
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Rambam Health Care Campus
Lead Sponsor
M
Monaldi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years with bloodstream infection or hospital-acquired or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB)
- CRAB must be resistant to meropenem or imipenem (MIC >8 µg/mL) and susceptible to cefiderocol (disc zone diameter ≥17 mm, MIC <2 µg/mL)
- CRAB susceptibility to other antibiotics does not affect inclusion
- CRAB must be isolated from respiratory samples within 7 days before pneumonia diagnosis if HAP or VAP is present
You will not qualify if you...
- More than 72 hours of antibiotic therapy active against CRAB within 96 hours before enrollment
- Infections with other carbapenem-susceptible pathogens considered clinically significant by doctors
- CRAB susceptible to any beta-lactam other than cefiderocol
- COVID-19 co-infection
- Immediate hypersensitivity to penicillin
- Pregnant women
- Previous participation in this trial
- Lack of informed consent as approved by ethics committees
- Infections requiring treatment longer than 14 days as determined by investigators
- Life expectancy less than 24 hours or antibiotics deemed futile
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Rambam Health Care Campus
Haifa, Israel
Actively Recruiting
2
Sheba Tel HaShomer Medical Campus
Ramat Gan, Israel
Actively Recruiting
3
Shamir Medical Center (Assaf Harofeh)
Tel Aviv, Israel
Actively Recruiting
Research Team
M
Mical Paul
CONTACT
M
Marco Falcone
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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