Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

Last updated: March 13, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sepsis And Septicemia

Soft Tissue Infections

Treatment

Reveal

Clinical Study ID

NCT06174649
Pro00109586
UM1AI104681
  • All Genders

Study 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

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

Exclusion Criteria:

  1. Positive blood culture for GNB within the prior 7 days (if known at the time of Gramstain result)

  2. Deceased at the time of Gram stain result

  3. Gram-positive bacilli, Gram-positive cocci, Gram-negative cocci, yeast, fungi, ormultiple morphologies of GNB detected on Gram stain of blood culture

  4. Previous enrollment in this study

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: Reveal
Phase:
Study Start date:
December 22, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Attikon University General Hospital

    Chaidari, Attiki 12462
    Greece

    Active - Recruiting

  • Tzaneio General Hospital

    Piraeus, 18536
    Greece

    Active - Recruiting

  • Kasturba Medical College, Mangalore

    Attavara, Mangalore 575001
    India

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 4428162
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas

    La Coruña, 15006
    Spain

    Site Not Available

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