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Completed

NCT Number: NCT06174649

Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

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.

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Key information

Conditions

Gram-negative Bacteremia Bloodstream Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attikon University General Hospital, Chaïdári, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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).

Primary outcomes

  1. Participant Clinical Outcomes, as Measured by Desirability of Outcome Ranking (DOOR)

    Time frame: Up to 30 days after Gram stain result

    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:

    • Alive without deleterious events
    • Alive with at least 1 deleterious event
    • Death

Secondary outcomes

  1. Number of Participants With All-Cause Mortality

    Time frame: Up to 30 days post Gram Stain

    All-cause in-hospital mortality up to 30 days post Gram stain result

  2. Hospital Stay Length

    Time frame: up to 30 days post Gram stain result

    Length of index stay in the hospital up to 30 days post Gram stain result, for those subjects alive at 30 days. Length of stay will be calculated as date of discharge minus date of Gram stain result.

  3. Number of Participants With ICU Admissions

    Time frame: up to 30 days post Gram stain result

    ICU admission up to 30 days post Gram stain result

  4. Number of Participants With New Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. Difficile

    Time frame: up to 30 days post Gram stain result

    New acquisition is defined as detection of MDRO/C. difficile in subjects who do not have preceding clinical or surveillance cultures with these organisms in the prior 3 months. MDRO will be identified on routine clinical or surveillance samples using local laboratory diagnostic procedures and include:

    Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus species 3rd generation cephalosporin-non-susceptible Enterobacterales Carbapenem-resistant Enterobacterales, as defined by the Center for Disease Control and Prevention: resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate produces a carbapenemase Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter species Candida auris

  5. Number of Participants With New Multidrug-Resistant Organism (MDRO)

    Time frame: up to 30 days post Gram stain result

    MDRO will be identified on routine clinical or surveillance samples using local laboratory diagnostic procedures and include:

    Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus species 3rd generation cephalosporin-non-susceptible Enterobacterales Carbapenem-resistant Enterobacterales, as defined by the Center for Disease Control and Prevention: resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate produces a carbapenemase Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter species Candida auris

  6. Number of Participants With C. Difficile

    Time frame: up to 30 days post Gram stain result

    Detection of C. difficile in subjects who do not have preceding clinical or surveillance cultures with these organisms in the prior 3 months.

  7. Number of Participants With MRSA

    Time frame: up to 30 days post Gram stain result

    Detection of Methicillin-resistant Staphylococcus aureus (MRSA)

  8. Number of Participants With VRE

    Time frame: up to 30 days post Gram stain result

    Detection of Vancomycin-resistant Enterococcus species (VRE)

  9. Number of Participants With CTX Resistant Enterobacterales

    Time frame: up to 30 days post Gram stain result

    Detection of 3rd generation cephalosporin-non-susceptible Enterobacterales (CTX resistant Enterobacterales)

  10. Number of Participants With CRE

    Time frame: up to 30 days post Gram stain result

    Detection of Carbapenem-resistant Enterobacterales (CRE)

  11. Number of Participants With MDR Pseudomonas

    Time frame: up to 30 days post Gram stain result

    Detection of Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (MDR Pseudomonas)

  12. Number of Participants With CRAb

    Time frame: up to 30 days post Gram stain result

    Detection of Carbapenem-resistant Acinetobacter species (CRAb)

  13. Number of Participants With Candida Auris

    Time frame: up to 30 days post Gram stain result

    Detection of Candida auris using local laboratory diagnostic precedures

  14. Time to Effective Antibiotic Therapy

    Time frame: within 3 days from Gram stain result

    Time to effective antibiotic therapy within 3 days from Gram stain result, defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on standard of care (SOC) AST.

  15. Receiving Effective Antibiotic Therapy Within 24 Hours

    Time frame: within 24 hours from Gram stain result

    Effective antibiotic therapy was defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on standard of care (SOC) AST and to which the isolate was not intrinsically resistant.

  16. Receiving Effective Antibiotic Therapy Within 3 Days

    Time frame: within 3 days from Gram stain result

    Effective antibiotic therapy was defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on standard of care (SOC) AST and to which the isolate was not intrinsically resistant.

  17. Time to Antibiotic Escalation or De-escalation

    Time frame: within 3 days from Gram stain result

    Time to antibiotic escalation or de-escalation of Gram negative coverage in those who have antibiotic change within 3 days from Gram stain result.

    Escalation: Changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral (PO) to intravenous (IV) route.

    De-escalation: Changing to a narrower spectrum antibiotic , cessation of one or more antibiotics, or changing from an IV to PO route of appropriate drug (i.e. IV to PO ciprofloxacin or levofloxacin).

  18. Antibiotic Change Within 3 Days

    Time frame: within 3 days from Gram stain result

    Antibiotic changes for Gram-negative coverage within 3 days from Gram stain result.

    Among as-randomized population, the antibiotic utilization can be categorized as follow: (a) first change is escalation, (b) first change is de-escalation, (c) no change, and (d) no Gram-negative antibiotic received within 3 days.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • BioMérieux
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Parexel

Registry information

Acronym: FAST

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2023
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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