| CTRI Number |
CTRI/2020/12/029794 [Registered on: 15/12/2020] Trial Registered Prospectively |
| Last Modified On: |
04/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Modified Antibiotic Susceptibility Testing |
|
Scientific Title of Study
|
Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia |
| Trial Acronym |
FAST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrikala Baliga |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Microbiology,
Kasturba Medical College, Light house Hill Road, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880049671 |
| Fax |
|
| Email |
shrikala.baliga@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shrikala Baliga |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Microbiology,
Kasturba Medical College, Light house Hill Road, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880049671 |
| Fax |
|
| Email |
shrikala.baliga@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shrikala Baliga |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Microbiology,
Kasturba Medical College, Light house Hill Road, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880049671 |
| Fax |
|
| Email |
shrikala.baliga@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore. Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Antibiotic Resistance Leadership Group |
| Address |
Duke University
Duke Box 102359 Hanes House, Trent Drive
Durham, NC USA 27710
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikala Baliga |
Department of Microbiology,Kasturba Medical College, Mangalore |
Kasturba Medical College, Mangalore, Light House Hill Road, Mangalore-575001
Dakshina Kannada
KARNATAKA |
9880049671
shrikala.baliga@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Positive blood culture with Gram stain showing GNB identified during local laboratory business hours |
|
| ExclusionCriteria |
| Details |
Positive blood culture for GNB at the same institution within prior 7 days (if known at the time of randomization), Deceased at the time of randomization, GNB plus Gram-positive bacterium, Gram-negative coccus, and/or yeast detected on Gram stain
• Previous enrollment in this study
• Not hospitalized
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We anticipate that patients whose blood cultures are characterized using DISK will have faster time to effective antibiotic therapy and better clinical outcomes than patients whose blood cultures are characterized using standard of care methods. |
one week of admission, date of discharge OR upto 30 days of hospitalisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We anticipate that patients whose blood cultures are characterized using DISK will have better antibiotic utilization and lesser irrational antibiotic therapy than patients whose blood cultures are characterized using standard of care methods. |
one week of admission, date of discharge OR upto 30 days of hospitalisation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Rapid antimicrobial susceptibility testing (AST) of Gram negative bacilli (GNB) from blood culture bottles may lead to earlier “pathogen-directed†antimicrobial therapy, better patient outcomes, and less antimicrobial resistance, compared to conventional testing. Objective: To evaluate the clinical impact of a rapid method for direct phenotypic AST of GNB from positive blood cultures versus Standard of Care (SOC), both implemented with antimicrobial stewardship team oversight. The rapid testing method involves disk diffusion AST direct from positive blood culture bottles, read between 8-10 hours of incubation. Design: This study is a 2-arm multinational prospective randomized controlled clinical trial. Hospitalized subjects with Gram-negative bacilli in blood cultures will be randomized to have blood cultures characterized using SOC vs. the rapid testing method in addition to SOC Outcomes: We will compare clinical outcomes and antimicrobial utilization between the arms. Subjects and timeline: 1000 subjects in 10 sites across 6 countries over approximately 2 years. Enrollment start date: September 2021. |