NCT06174649

Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Gram-negative Bacteremia
• Bloodstream Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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).

Timeline

• Start date: 2023-12-22
• Primary completion: 2025-06-18
• Completion: 2025-06-18
• First posted: 2023-12-18
• Last updated: 2025-07-08

Locations

7 sites across 4 countries: Greece, India, Israel, Spain