Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
- Conditions
- Gram-negative BacteremiaBloodstream Infection
- Interventions
- Diagnostic Test: Reveal
- Registration Number
- NCT06174649
- Lead Sponsor
- Duke University
- Brief Summary
This study is a 2-arm, multicenter, multinational, prospective, randomized, controlled clinical trial. Hospitalized subjects with blood cultures growing Gram negative bacilli (GNB) will be randomized 1:1 to have the positive blood cultures characterized using standard of care (SOC) antimicrobial susceptibility testing (AST) vs. a rapid AST method known as Reveal™ in addition to SOC AST. The purpose of the FAST trial is to evaluate whether use of a rapid phenotypic AST improves clinical outcomes compared to use of SOC AST methods in clinical settings with high resistance rates.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- Positive blood culture with Gram stain showing GNB
- Hospitalized at the time of Gram stain result
- Positive blood culture for GNB at the same institution within the prior 7 days (if known at the time of Gram stain result)
- Deceased at the time of Gram stain result
- Gram-positive bacilli, Gram-positive cocci, Gram-negative cocci, yeast, fungi, or multiple morphologies of GNB detected on Gram stain of blood culture
- Previous enrollment in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reveal Reveal When a blood culture growing GNB is randomized to the Reveal arm, the positive blood culture will be characterized using Reveal, a rapid AST, and the standard of care AST.
- Primary Outcome Measures
Name Time Method Subject Clinical Outcomes, as measured by Desirability of Outcome Ranking (DOOR) Up to 30 days after Gram stain result The composite 3-category DOOR outcome will assess three deleterious events (unsuccessful discharge, lack of clinical response, and undesirable events) in addition to survival up to 30 days after Gram stain result. The primary DOOR outcome measure is defined using three ordered levels. From best to worst, they are:
1. Alive without deleterious events
2. Alive with at least 1 deleterious event
3. Death
- Secondary Outcome Measures
Name Time Method Time to antibiotic escalation within 3 days from Gram stain result Time to antibiotic escalation of Gram negative coverage in those who have antibiotic escalation within 3 days from Gram stain result.
Escalation: Changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral (PO) to intravenous (IV) route.Hospital Stay Length up to 30 days post Gram stain result Length of index stay in the hospital up to 30 days post Gram stain result, for those subjects alive at 30 days. Length of stay will be calculated as date of discharge minus date of Gram stain result.
Number of participants with new Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. difficile up to 30 days post Gram stain result New acquisition is defined as detection of MDRO/C. difficile in subjects who do not have preceding clinical or surveillance cultures with these organisms in the prior 3 months. MDRO will be identified on routine clinical or surveillance samples using local laboratory diagnostic procedures and include:
Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus species 3rd generation cephalosporin-non-susceptible Enterobacterales Carbapenem-resistant Enterobacterales, as defined by the Center for Disease Control and Prevention: resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate produces a carbapenemase Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter species Candida aurisTime to effective antibiotic therapy within 3 days from Gram stain result Time to effective antibiotic therapy within 3 days from Gram stain result, defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on standard of care (SOC) AST.
Time to antibiotic de-escalation of Gram negative coverage within 3 days from Gram stain result Time to antibiotic de-escalation of Gram negative coverage in those who have antibiotic de-escalation within 3 days from Gram stain result.
De-escalation: Changing to a narrower spectrum antibiotic , cessation of one or more antibiotics, or changing from an IV to PO route of appropriate drug (i.e. IV to PO ciprofloxacin or levofloxacin).All-Cause Mortality Up to 30 days post Gram Stain All-cause in-hospital mortality up to 30 days post Gram stain result
Number of ICU admissions up to 30 days post Gram stain result ICU admission up to 30 days post Gram stain result
Trial Locations
- Locations (7)
Attikon University General Hospital
🇬🇷Chaidari, Attiki, Greece
Tzaneio General Hospital
🇬🇷Piraeus, Greece
Kasturba Medical College, Mangalore
🇮🇳Attavara, Mangalore, India
Rambam Health Care Campus
🇮🇱Haifa, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas
🇪🇸La Coruña, Spain