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Completed
NCT06174649
Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
Conditions: Gram-negative Bacteremia, Bloodstream Infection
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 899
Sponsor: Duke University
Location: Attikon University General Hospital Chaïdári Attica
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.
Eligibility Criteria
Inclusion Criteria:
1. Positive blood culture with Gram stain showing GNB.
2. Hospitalized at the time of Gram stain result.
3. Enrolled within 16 hours of blood culture positivity.
Exclusion Criteria:
1. Positive blood culture for GNB within the prior 7 days (if known at the time of Gram stain result).
2. Deceased at the time of Gram stain result.
3. Gram-positive bacilli, Gram-positive cocci, Gram-negative cocci, yeast, fungi, or multiple morphologies of GNB detected on Gram stain of blood culture.
4. Previous enrollment in this study.
Source: ClinicalTrials.gov (NCT06174649). StuddyBuddy aggregates publicly available trial information.