NCT05922124 Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
| NCT ID | NCT05922124 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rambam Health Care Campus |
| Condition | Carbapenem Resistant Bacterial Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 734 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 734 participants in total. It began in 2024-09-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Marco Falcone
PRINCIPAL INVESTIGATOR
Pisa University Hospital
Frequently Asked Questions
Who can join the NCT05922124 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Carbapenem Resistant Bacterial Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05922124 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05922124 currently recruiting?
Yes, NCT05922124 is actively recruiting participants. Contact the research team at paulm@technion.ac.il for enrollment information.
Where is the NCT05922124 trial being conducted?
This trial is being conducted at Haifa, Israel, Ramat Gan, Israel, Tel Aviv, Israel.
Who is sponsoring the NCT05922124 clinical trial?
NCT05922124 is sponsored by Rambam Health Care Campus. The principal investigator is Marco Falcone at Pisa University Hospital. The trial plans to enroll 734 participants.