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

Launched by RAMBAM HEALTH CARE CAMPUS · Jun 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new treatment combining cefiderocol and ampicillin-sulbactam compared to the standard treatments of colistin alone or colistin with meropenem. It focuses on adults who have serious infections caused by a type of bacteria called carbapenem-resistant Acinetobacter baumannii (CRAB), which can lead to bloodstream infections or pneumonia acquired in the hospital or from a ventilator. The goal is to find out which treatment works better against these tough-to-treat infections.

To be eligible for this trial, participants must be adults over 18 years old who have confirmed CRAB infections that do not respond to commonly used antibiotics. However, some people may not qualify, including those who have already received certain antibiotics for more than 72 hours before joining the study, pregnant women, or those with specific health conditions. If you choose to participate, you will receive one of the treatments being studied and will be closely monitored by the research team to evaluate your response. It's important to note that this study is not yet recruiting participants, so if you're interested, you may need to wait for it to begin.

Gender

ALL

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