Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial (FAST)

Duke University

Status: Completed

Conditions: Gram-negative Bacteremia; Bloodstream Infection

Treatments: Diagnostic Test: Reveal

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06174649

UM1AI104681 (U.S. NIH Grant/Contract)

Pro00109586

Details and patient eligibility

About

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.

Enrollment: 900 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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900 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

When a blood culture growing GNB is randomized standard of care arm the positive blood cultures will be characterized using standard of care antimicrobial susceptibility testing (AST)

Reveal

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Reveal