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New treatment option for Carbapenem Resistant Bacterial Infection
Official title Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
ClinicalTrials.gov ID: NCT05922124
What this study is testing
What is Cefiderocol?
Cefiderocol is an investigational medicine, being studied as a potential treatment for carbapenem resistant bacterial infection.
Also referred to as Fetroja.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Adults \>18 years with bacteremia or hospital-acquired pneumonia (HAP)/ ventilator-associated pneumonia (VAP) (Table 3) caused by...
You likely can't join if
- 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...
- CRAB susceptible any beta-lactam other than cefiderocol
- Coronavirus 2019 (COVID-19) co-infection
- Immediate-type hypersensitivity to penicillin
- Pregnant women
See the full eligibility 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...
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Haifa, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haifa, Israel; Ramat Gan, Israel; Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.