Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

NCT06174649 | Completed DMC

• 2 other identifiers: Pro00109586UM1AI104681
• Study Type: interventional
• Target: 900
• Locations: 4 countries
• Sites: 7

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.

Conditions

Gram-negative Bacteremia; Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• Subject Clinical Outcomes, as measured by Desirability of Outcome Ranking (DOOR)

  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

  Up to 30 days after Gram stain result

Secondary Outcomes (7)

• All-Cause Mortality

  Up to 30 days post Gram Stain

• Hospital Stay Length

  up to 30 days post Gram stain result

• Number of ICU admissions

  up to 30 days post 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

• Time to effective antibiotic therapy

  within 3 days from Gram stain result

Study Arms (2)

Standard of Care

NO INTERVENTION

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

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.

Diagnostic Test: Reveal

Interventions

Reveal DIAGNOSTIC_TEST

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).

Reveal

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive blood culture with Gram stain showing GNB
• Hospitalized at the time of Gram stain result
• Enrolled within 16 hours of blood culture positivity

You may not qualify if:

• Positive blood culture for GNB 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Parexel: collaborator
• BioMérieux: collaborator

Study Sites (7)

Attikon University General Hospital

Chaïdári, Attica, 12462, Greece

Location

Tzaneio General Hospital

Piraeus, 18536, Greece

Location

Kasturba Medical College, Mangalore

Attavāra, Mangalore, 575001, India

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, 4428162, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas

A Coruña, 15006, Spain

Location

Related Publications (1)

• Banerjee R, Komarow L, Li Y, Wu Q, Sanchez-Gonzalez L, Mau D, Abbenante E, Schwager N, Dodd A, Souli M, Geres HS, Doernberg S, Greenwood-Quaintance K, Evans SR, Chambers HF, Fowler VG Jr, Patel R; Antibacterial Resistance Leadership Group. Study protocol for a multicenter, multinational prospective randomized controlled trial comparing outcomes in subjects with Gram-negative bacteremia who have blood culture evaluation using Fast Antibiotic Susceptibility Testing vs. standard of care testing: the FAST trial. Trials. 2025 Nov 12;26(1):500. doi: 10.1186/s13063-025-09228-4.

  PMID: 41225518 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ritu Banerjee, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Vance Fowler, MD

  Duke Clinical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patient and care provider will not know which arm subject is randomized into until after the stewardship team has review the Reveal results and provided feedback on initial therapies prescribed.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 18, 2023
• Study Start: December 22, 2023
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: July 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); GR (2); IL (3); ES (1)