Evidence map›Paper›PMID 41225518›Full record

ArticleTrials2025

Study protocol for a multicenter, multinational prospective randomized controlled trial comparing outcomes in subjects with Gram-negative bacteremia who have blood culture evaluation using Fast Antibiotic Susceptibility Testing vs. standard of care testing: the FAST trial.

Ritu Banerjee, Lauren Komarow, Yixuan Li, Qihang Wu, Lucia Sanchez-Gonzalez, Donald Mau, Erin Abbenante, Nyssa Schwager, Andrew Dodd, Maria Souli and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06174649 (Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06174649 nacompletednot on this map

Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

TypeinterventionalSponsorDuke UniversityRan2023 to 2025Enrolled899ConditionsGram-negative Bacteremia, Bloodstream InfectionArmsReveal
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Ritu BanerjeeDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA. ritu.banerjee@vumc.org.ORCID http://orcid.org/0000-0002-5910-7430
Lauren KomarowThe Biostatistics Center, George Washington University, Rockville, MD, USA.
Yixuan LiThe Biostatistics Center, George Washington University, Rockville, MD, USA.
Qihang WuThe Biostatistics Center, George Washington University, Rockville, MD, USA.
Lucia Sanchez-GonzalezThe Biostatistics Center, George Washington University, Rockville, MD, USA.
Donald MauDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Erin AbbenanteDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Nyssa SchwagerDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Andrew DoddDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Maria SouliDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Holly S GeresDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Sarah DoernbergDepartment of Medicine, University of California, San Francisco, CA, USA.
Kerryl Greenwood-QuaintanceDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Scott R EvansThe Biostatistics Center, George Washington University, Rockville, MD, USA.
Henry F ChambersDepartment of Medicine, University of California, San Francisco, CA, USA.
Vance G FowlerDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Robin PatelDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Antibacterial Resistance Leadership Group

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases UM1AI104681NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

backgroundNovel, rapid blood culture diagnostics can provide faster antibiotic susceptibility results (AST) compared to standard methods but their impact on clinical outcomes is unclear and not assessed in many prospective clinical trials.

methodsThis study is a two-arm, multicenter, multinational, prospective randomized controlled clinical trial conducted in countries with high antibiotic resistance rates including Greece, India, Israel, and Spain. Nine hundred hospitalized subjects who have blood cultures collected as part of routine clinical care with growth of Gram-negative bacilli (GNB) will be randomized 1:1 to blood culture evaluation using standard of care (SOC) AST vs. a rapid phenotypic AST method, VITEK REVEAL™ in addition to SOC AST. Subjects in both study arms will be reviewed by antibiotic stewardship clinicians who will recommend changes to antibiotic therapy, if indicated. The primary outcome is a composite three-category Desirability of Outcome Ranking (DOOR) defined using three ordered levels: alive without deleterious events, alive with at least one deleterious event, and death. Key secondary outcomes include mortality, length of stay, and time to antibiotic escalation or de-escalation within 3 days of randomization. Exploratory outcomes include a five-category DOOR, categorial agreement between VITEK REVEAL™ and SOC testing, clinician compliance with antibiotic stewardship recommendations, and desirability of treatment selection based on antibiotic spectrum, activity, and bloodstream isolate susceptibility profile (DOOR MAT). The primary analysis will be conducted on the modified intention-to-treat population. DISCUSSION: This trial will evaluate whether use of a rapid phenotypic AST method improves outcomes compared to use of conventional methods for patients with Gram-negative bloodstream infections in clinical settings with high antibiotic resistance rates.

trial registrationClinicalTrials.gov ID NCT06174649. Registered on Dec 18 2023. PROTOCOL VERSION: Number 20-0021, version 5.0, 11-April-2024.

Indexed as

Anti-Bacterial AgentsBacteremiaBlood CultureGram-Negative BacteriaGram-Negative Bacterial InfectionsAntimicrobial StewardshipHumansIsraelMicrobial Sensitivity TestsMulticenter Studies as TopicPredictive Value of TestsProspective StudiesRandomized Controlled Trials as TopicStandard of CareTime FactorsTreatment OutcomeAnti-Bacterial AgentsAntibiotic susceptibility testingBacteremiaBloodstream infectionGram-negative

Identifiers

PMID41225518
PMCPMC12613732

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.