Gram-negative BacteremiaFASTNCT06174649
Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
A study testing Reveal in people with Gram-negative Bacteremia and Bloodstream Infection, run by Duke University at 7 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gram-negative Bacteremia, Bloodstream Infection
- What is being tested?
- Reveal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 899 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 22 Dec 2023to 18 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive blood culture with Gram stain showing GNB.
- Hospitalized at the time of Gram stain result.
- Enrolled within 16 hours of blood culture positivity.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Israel3 sites
Rambam Health Care Campus
Haifa, 3109601
Meir Medical Center
Kfar Saba, 4428162
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Greece2 sites
Attikon University General Hospital
Chaïdári, Attica, 12462
Tzaneio General Hospital
Piraeus, 18536
Spain1 site
Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas
A Coruña, 15006
About this study
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.
- Conditions
- Gram-negative Bacteremia, Bloodstream Infection
- Being tested
- Reveal
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevealDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | When a blood culture growing GNB is randomized standard of care arm the positive blood cultures will be characterized using standard of care antimicrobial susceptibility testing (AST) |
| Reveal | Active comparator | When a blood culture growing GNB is randomized to the Reveal arm, the positive blood culture will be characterized using Reveal, a rapid AST, and the standard of care AST. Receives: Diagnostic Test: Reveal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant 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
Measured: Up to 30 days after Gram stain result
Secondary outcomes (18)
Number of Participants With All-Cause Mortality
All-cause in-hospital mortality up to 30 days post Gram stain result
Measured: Up to 30 days post Gram Stain
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.
Measured: up to 30 days post Gram stain result
Number of Participants With ICU Admissions
ICU admission up to 30 days post Gram stain result
Measured: up to 30 days post Gram stain result
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
Measured: up to 30 days post Gram stain result
Number of Participants With New Multidrug-Resistant Organism (MDRO)
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
Measured: up to 30 days post Gram stain result
Number of Participants With C. Difficile
Detection of C. difficile in subjects who do not have preceding clinical or surveillance cultures with these organisms in the prior 3 months.
Measured: up to 30 days post Gram stain result
Number of Participants With MRSA
Detection of Methicillin-resistant Staphylococcus aureus (MRSA)
Measured: up to 30 days post Gram stain result
Number of Participants With VRE
Detection of Vancomycin-resistant Enterococcus species (VRE)
Measured: up to 30 days post Gram stain result
Number of Participants With CTX Resistant Enterobacterales
Detection of 3rd generation cephalosporin-non-susceptible Enterobacterales (CTX resistant Enterobacterales)
Measured: up to 30 days post Gram stain result
Number of Participants With CRE
Detection of Carbapenem-resistant Enterobacterales (CRE)
Measured: up to 30 days post Gram stain result
Number of Participants With MDR Pseudomonas
Detection of Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (MDR Pseudomonas)
Measured: up to 30 days post Gram stain result
Number of Participants With CRAb
Detection of Carbapenem-resistant Acinetobacter species (CRAb)
Measured: up to 30 days post Gram stain result
Number of Participants With Candida Auris
Detection of Candida auris using local laboratory diagnostic precedures
Measured: up to 30 days post Gram stain result
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.
Measured: within 3 days from Gram stain result
Receiving Effective Antibiotic Therapy Within 24 Hours
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.
Measured: within 24 hours from Gram stain result
Receiving Effective Antibiotic Therapy Within 3 Days
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.
Measured: within 3 days from Gram stain result
Time to Antibiotic Escalation or De-escalation
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).
Measured: within 3 days from Gram stain result
Antibiotic Change Within 3 Days
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.
Measured: within 3 days from Gram stain result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start22 Dec 2023
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gram-negative BacteremiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Parexel, BioMérieux
- Responsible party
- Sponsor
- Investigators
- Ritu Banerjee, MD, PhD, Principal investigator, Vanderbilt University Medical CenterVance Fowler, MD, Study director, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174649
- Sponsor's protocol ID
- Pro00109586
- Other IDs
- UM1AI104681
- Acronym
- FAST
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2023
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banerjee R, Komarow L, Li Y, Mau D, Dodd A, Geres H, Greenwood-Quaintance K, Adler A, Baliga S, Chowers M, Chrysos G, Zarkotou O, Paul M, Pournaras S, Regueiro DS, Evans S, Chambers H, Fowler VG Jr, Patel R; Antibacterial Resistance Leadership Group. Fast Antimicrobial Susceptibility Testing for Gram-Negative Bacteremia: The FAST Randomized Clinical Trial. JAMA. 2026 May 26;335(20):1762-1773. doi: 10.1001/jama.2026.5487.
PubMed 41999287Banerjee R, Komarow L, Li Y, Wu Q, Sanchez-Gonzalez L, Mau D, Abbenante E, Schwager N, Dodd A, Souli M, Geres HS, Doernberg S, Greenwood-Quaintance K, Evans SR, Chambers HF, Fowler VG Jr, Patel R; Antibacterial Resistance Leadership Group. 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. Trials. 2025 Nov 12;26(1):500. doi: 10.1186/s13063-025-09228-4.
PubMed 41225518
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
- ClinicalTrials.gov ID
- NCT06174649
- Acronym / sponsor ID
- FAST / Pro00109586
- Conditions
- Gram-negative Bacteremia, Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Parexel, BioMérieux
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –When a blood culture growing GNB is randomized standard of care arm the positive blood cultures will be characterized using standard of care antimicrobial susceptibility testing (AST) |
| Reveal | Active comparator | Diagnostic Test: RevealWhen a blood culture growing GNB is randomized to the Reveal arm, the positive blood culture will be characterized using Reveal, a rapid AST, and the standard of care AST. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Positive blood culture with Gram stain showing GNB.
- Hospitalized at the time of Gram stain result.
- Enrolled within 16 hours of blood culture positivity.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevealReveal 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). | Diagnostic test | Reveal |
Primary outcome
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: 1. Alive without deleterious events 2. Alive with at least 1 deleterious event 3. Death
18 secondary outcomes
Number of Participants With All-Cause Mortality
Time frame: Up to 30 days post Gram Stain
Hospital Stay Length
Time frame: up to 30 days post Gram stain result
Number of Participants With ICU Admissions
Time frame: up to 30 days post Gram stain result
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
Number of Participants With New Multidrug-Resistant Organism (MDRO)
Time frame: up to 30 days post Gram stain result
Number of Participants With C. Difficile
Time frame: up to 30 days post Gram stain result
Number of Participants With MRSA
Time frame: up to 30 days post Gram stain result
Number of Participants With VRE
Time frame: up to 30 days post Gram stain result
Number of Participants With CTX Resistant Enterobacterales
Time frame: up to 30 days post Gram stain result
Number of Participants With CRE
Time frame: up to 30 days post Gram stain result
Number of Participants With MDR Pseudomonas
Time frame: up to 30 days post Gram stain result
Number of Participants With CRAb
Time frame: up to 30 days post Gram stain result
Number of Participants With Candida Auris
Time frame: up to 30 days post Gram stain result
Time to Effective Antibiotic Therapy
Time frame: within 3 days from Gram stain result
Receiving Effective Antibiotic Therapy Within 24 Hours
Time frame: within 24 hours from Gram stain result
Receiving Effective Antibiotic Therapy Within 3 Days
Time frame: within 3 days from Gram stain result
Time to Antibiotic Escalation or De-escalation
Time frame: within 3 days from Gram stain result
Antibiotic Change Within 3 Days
Time frame: within 3 days from Gram stain result
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41999287Banerjee R, Komarow L, Li Y, Mau D, Dodd A, Geres H, Greenwood-Quaintance K, Adler A, Baliga S, Chowers M, Chrysos G, Zarkotou O, Paul M, Pournaras S, Regueiro DS, Evans S, Chambers H, Fowler VG Jr, Patel R; Antibacterial Resistance Leadership Group. Fast Antimicrobial Susceptibility Testing for Gram-Negative Bacteremia: The FAST Randomized Clinical Trial. JAMA. 2026 May 26;335(20):1762-1773. doi: 10.1001/jama.2026.5487.
- Derived from this study: PubMed 41225518Banerjee R, Komarow L, Li Y, Wu Q, Sanchez-Gonzalez L, Mau D, Abbenante E, Schwager N, Dodd A, Souli M, Geres HS, Doernberg S, Greenwood-Quaintance K, Evans SR, Chambers HF, Fowler VG Jr, Patel R; Antibacterial Resistance Leadership Group. 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. Trials. 2025 Nov 12;26(1):500. doi: 10.1186/s13063-025-09228-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritu Banerjee, MD, PhD principal investigator
Vanderbilt University Medical Center
Vance Fowler, MD study director
Duke Clinical Research Institute
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reveal in people with Gram-negative Bacteremia and Bloodstream Infection, run by Duke University at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel, Greece, India, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Clinical Outcomes, as Measured by Desirability of Outcome Ranking (DOOR) (time frame: Up to 30 days after Gram stain result). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174649, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.