Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

Not Applicable

Completed

• Conditions: Gram-negative Bacteremia; Bloodstream Infection

• Registration Number: NCT06174649
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-18
• Study Start: 2023-12-22
• Status Verified: 2024-12
• Primary Completion: 2025-06-18
• Study Completion: 2025-06-18
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Positive blood culture with Gram stain showing GNB
2. Hospitalized at the time of Gram stain result

Exclusion Criteria

1. Positive blood culture for GNB at the same institution 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subject Clinical Outcomes, as measured by Desirability of Outcome Ranking (DOOR)	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: 1. Alive without deleterious events; 2. Alive with at least 1 deleterious event; 3. Death

Secondary Outcome Measures

Name	Time	Method
Time to antibiotic escalation	within 3 days from Gram stain result	Time to antibiotic escalation of Gram negative coverage in those who have antibiotic escalation 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.
Hospital Stay Length	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.
Number of participants with new Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. difficile	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
Time to effective antibiotic therapy	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.
Time to antibiotic de-escalation of Gram negative coverage	within 3 days from Gram stain result	Time to antibiotic de-escalation of Gram negative coverage in those who have antibiotic de-escalation within 3 days from Gram stain result.; 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).
All-Cause Mortality	Up to 30 days post Gram Stain	All-cause in-hospital mortality up to 30 days post Gram stain result
Number of ICU admissions	up to 30 days post Gram stain result	ICU admission up to 30 days post Gram stain result

Trial Locations

Locations (7)

Attikon University General Hospital; 🇬🇷 Chaidari, Attiki, Greece

Tzaneio General Hospital; 🇬🇷 Piraeus, Greece

Kasturba Medical College, Mangalore; 🇮🇳 Attavara, Mangalore, India

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas; 🇪🇸 La Coruña, Spain