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

RecruitingPhase 4Ages 16 Years - anyAllRambam Health Care Campus
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮผg/mL) susceptible to cefiderocol (disc zone diameter \>=17 mm, corresponding to an MIC \<2 ฮผg/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
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What it tests

  • Cefiderocol
  • Ampicillin-sulbactam
  • Colistin
  • Meropenem
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Where

3 sites
Rambam Health Care Campus
Haifa, Israel
Sheba Tel HaShomer Medical Campus
Ramat Gan, Israel
Shamir Medical Center (Assaf Harofeh)
Tel Aviv, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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