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

RecruitingPhase 4

Sponsor: Rambam Health Care Campus

Conditions: Carbapenem Resistant Bacterial Infection, Acinetobacter Bacteremia, Acinetobacter Pneumonia

Interventions: Cefiderocol, Ampicillin-sulbactam, Colistin, Meropenem

Countries: Israel

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.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (3)

Haifa, Israel
Ramat Gan, Israel
Tel Aviv, Israel