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CTRI Number  CTRI/2024/04/065949 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial (FAST) 
Scientific Title of Study   Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
20-0021, v4.0, dated 23 Nov 2022  Protocol Number 
NCT06174649  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Annappa Kamath 
Designation  Executive Director Project Leadership- BIOTECH CLIENT DELIVERY MANAGEMENT 
Affiliation  PAREXEL International Clinical Research Private Limited 
Address  CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village

Bangalore
KARNATAKA
560103
India 
Phone  918067723000  
Fax  918067723001  
Email  Annappa.Kamath@parexel.com  
 
Details of Contact Person
Public Query  
Name  Dr Annappa Kamath 
Designation  Executive Director Project Leadership- BIOTECH CLIENT DELIVERY MANAGEMENT 
Affiliation  PAREXEL International Clinical Research Private Limited 
Address  CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village

Bangalore
KARNATAKA
560103
India 
Phone  918067723000  
Fax  918067723001  
Email  Annappa.Kamath@parexel.com  
 
Source of Monetary or Material Support  
M/s Duke University, 300 West Morgan, Street, Suite 800, Durham, North Carolina USA 
 
Primary Sponsor  
Name  M/s Duke University 
Address  300 West Morgan, Street, Suite 800, Durham, North Carolina USA 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Parexel International Clinical Research Private Limited  CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA 
 
Countries of Recruitment     Israel
Greece
India
Spain  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrikala Baliga   Kasturba Medical College  Department of Microbiology, Kasturba Medical College, Light House Hill Road, Mangalore, Manipal Academy of Higher Education, Manipal
Dakshina Kannada
KARNATAKA 		 919880049671

shrikala.baliga@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Office of Medical Educational Unit, Kasturba medical College, Light House Hill Road, Mangalore-575001, Karnataka, India   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R788||Finding of other specified substances, not normally found in blood,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  RevealTM testing Standard culture and susceptibility Stewardship clinician review   • Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) will be used as the standard clinical organism identification method. • RevealTM testing will be performed according to the manufacturer’s instructions and reported in the subject’s MR. RevealTM AST must be initiated less than 16 hours after the blood culture bottle is flagged positive. Gram negative bacilli (GNB)/antibiotic combinations not reported by RevealTM, but routinely reported by the local Microbiology Laboratory using SOC testing, will be added to the final AST report for study subjects. • SOC culture and AST will be performed. • Stewardship clinicians will review results and provide recommendations to the treating providers.  
Comparator Agent  Standard culture and Susceptibility Stewardship Clinician review   • Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) will be used as the standard clinical organism identification method • Local SOC AST of GNB from positive blood cultures will be performed. • Stewardship clinicians will review results and provide recommendations to the treating providers.  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Positive blood culture with Gram stain showing GNB
Hospitalized at the time of Gram stain result
 
 
ExclusionCriteria 
Details  Positive blood culture for GNB at the same institution 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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures of subject disposition and deleterious events will be collected in order to assess the DOOR outcome up to 30 days after Gram stain result. The primary DOOR outcome measure is defined using three ordered levels: From best to worse they are alive without deleterious events; alive with 1 deleterious event; death.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
All-cause in-hospital mortality up to 30 days post Gram stain result  30 days 
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.  30 days 
ICU admission up to 30 days post Gram stain result  30 days 
New acquisition of multidrug resistant organism and or or C. difficile after Gram stain result and up to 30 days post Gram stain result. New acquisition is defined as detection of MDRO or 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  30 days 
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 SOC AST.  3 days 
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.
 		 3 days 
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.
 		 3 days 
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).
 		 3 days 
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="85" 
Final Enrollment numbers achieved (Total)= "103"
Final Enrollment numbers achieved (India)="900" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/05/2024 
Date of Study Completion (India) 16/06/2025 
Date of First Enrollment (Global)  27/12/2023 
Date of Study Completion (Global) 17/06/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 RevealTM 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.  
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