Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

Bloodstream Infection Clinical Trial

— FAST  

Official title:

Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174649
• Other study ID #: Pro00109586
• Secondary ID: UM1AI104681
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: Ritu Banerjee, MD, PhD
• Phone: 615-322-3157
• Email: ritu.banerjee[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Bloodstream Infection
• Gram-negative Bacteremia
• Sepsis

Intervention

Diagnostic Test:
• Reveal
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).

Locations

Country	Name	City	State
Greece	Attikon University General Hospital	Chaidari	Attiki
Greece	Tzaneio General Hospital	Piraeus
India	Kasturba Medical College, Mangalore	Attavara	Mangalore
Israel	Rambam Health Care Campus	Haifa
Israel	Meir Medical Center	Kfar Saba
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Spain	Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas	La Coruña

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	BioMérieux, National Institute of Allergy and Infectious Diseases (NIAID), Parexel

Countries where clinical trial is conducted

Greece,  India,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Alive without deleterious events; Alive with at least 1 deleterious event; Death	Up to 30 days after Gram stain result
Secondary	All-Cause Mortality	All-cause in-hospital mortality up to 30 days post Gram stain result	Up to 30 days post Gram Stain
Secondary	Hospital Stay Length	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.	up to 30 days post Gram stain result
Secondary	Number of ICU admissions	ICU admission up to 30 days post Gram stain result	up to 30 days post Gram stain result
Secondary	Number of participants with new Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. difficile	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	up to 30 days post Gram stain result
Secondary	Time to effective antibiotic therapy	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.	within 3 days from Gram stain result
Secondary	Time to antibiotic escalation	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.	within 3 days from Gram stain result
Secondary	Time to antibiotic de-escalation of Gram negative coverage	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).	within 3 days from Gram stain result