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Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
Sponsor: Duke University
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
899
Start Date
2023-12-22
Completion Date
2025-06-18
Last Updated
2026-07-28
Healthy Volunteers
No
Interventions
Reveal
Reveal is a rapid AST method, which uses small molecule sensor technology to detect growth of bacterial populations by measuring volatile metabolites, and provides AST results in \~5 hours. Reveal™ is approved for clinical use in the European Union (EU) and Israel and approval is in process in India, and provides minimum inhibitory concentrations (MICs) for 28 antibiotics and 9 Gram negative species, that together account for \~90% of organisms causing Gram negative blood stream infections (BSI).
Locations (7)
Attikon University General Hospital
Chaïdári, Attica, Greece
Tzaneio General Hospital
Piraeus, Greece
Kasturba Medical College, Mangalore
Attāvara, 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
A Coruña, Spain