Cefiderocol plus ampicillin‑sulbactam versus colistin (with or without meropenem) for carbapenem‑resistant Acinetobacter infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, controlled cohort in which consecutive consenting adults with CRAB bloodstream infection, hospital‑acquired pneumonia, or ventilator‑associated pneumonia will receive cefiderocol plus ampicillin‑sulbactam at five hospitals in Israel and Italy. The planned CASCADE cohort of about 150 patients will be compared against historical CRAB patients from two recently completed randomized trials (AIDA and OVERCOME) that treated patients with colistin ± meropenem. Inclusion requires CRAB isolates susceptible to cefiderocol and limits prior effective therapy; polymicrobial carbapenem‑susceptible infections are excluded. Outcomes will be compared across cohorts to determine whether the cefiderocol combination yields better clinical results than the historical colistin‑based regimens.

Why it matters

Who can join: the full rules

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

Where it's running

• Rambam Health Care Campus
  Haifa, Israel Recruiting
• Sheba Tel HaShomer Medical Campus
  Ramat Gan, Israel Recruiting
• Shamir Medical Center (Assaf Harofeh)
  Tel Aviv, Israel Recruiting

Study contacts

• Principal investigator: Marco Falcone — Pisa University Hospital
• Study coordinator: Mical Paul
• Email: paulm@technion.ac.il
• Phone: 0502062140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.