Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborators: Assaf-Harofeh Medical Center; Monaldi Hospital; Pisa University Hospital; Rutgers Robert Wood Johnson Medical School; Sheba Medical Center
• Treatments: Ampicillin; Cefiderocol; Colistin; Meropenem; Sulbactam; Sultamicillin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

• 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