Clinical trial NCT06174649: Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
Official title: Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gram-negative Bacteremia
Bloodstream Infection
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Parexel
name: BioMérieux
First posted: 2023-12-18
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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 Criteria:

1. Positive blood culture for GNB 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

Primary outcomes:
measure: Subject Clinical Outcomes, as measured by Desirability of Outcome Ranking (DOOR)
timeFrame: Up to 30 days after Gram stain result
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: Up to 30 days post Gram Stain
measure: Hospital Stay Length
timeFrame: up to 30 days post Gram stain result
measure: Number of ICU admissions
timeFrame: up to 30 days post Gram stain result
measure: Number of participants with new Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. difficile
timeFrame: up to 30 days post Gram stain result
measure: Time to effective antibiotic therapy
timeFrame: within 3 days from Gram stain result
measure: Time to antibiotic escalation
timeFrame: within 3 days from Gram stain result
measure: Time to antibiotic de-escalation of Gram negative coverage
timeFrame: within 3 days from Gram stain result
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Attikon University General Hospital
state: Attiki
city: Piraeus
country: Greece
facility: Tzaneio General Hospital
city: Attavara
country: India
facility: Kasturba Medical College, Mangalore
state: Mangalore
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ritu Banerjee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Clinical Research Institute
name: Vance Fowler, MD
role: STUDY_DIRECTOR
References: