| CTRI Number |
CTRI/2022/08/044804 [Registered on: 22/08/2022] Trial Registered Prospectively |
| Last Modified On: |
18/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Centralized TB Assay Solutions |
|
Scientific Title of Study
|
Multicentre trial to assess the
performance of centralized assay
solutions for detection of MTB and resistance to Rifampin and Isoniazid |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol : 7213-00-2/1 v1.5 14-January-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Priya |
| Designation |
Scientist C, Department of Bacteriology |
| Affiliation |
ICMR- National Institute for Research in Tuberculosis |
| Address |
Department of Bacteriology, ICMR-NIRT, Ground Floor, No 1, Major Sathiyamoorthy road, Chetpet, Chennai.
Chennai
TAMIL NADU
600031
India |
| Phone |
04428369660 |
| Fax |
|
| Email |
priya.raj@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Priya |
| Designation |
Scientist C, Department of Bacteriology |
| Affiliation |
ICMR- National Institute for Research in Tuberculosis |
| Address |
Department of Bacteriology, ICMR-NIRT, Ground Floor, No 1, Major Sathiyamoorthy road, Chetpet, Chennai.
Chennai
TAMIL NADU
600031
India |
| Phone |
04428369660 |
| Fax |
|
| Email |
priya.raj@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Priya |
| Designation |
Scientist C, Department of Bacteriology |
| Affiliation |
ICMR- National Institute for Research in Tuberculosis |
| Address |
Department of Bacteriology, ICMR-NIRT, Ground Floor, No 1, Major Sathiyamoorthy road, Chetpet, Chennai.
Chennai
TAMIL NADU
600031
India |
| Phone |
04428369660 |
| Fax |
|
| Email |
priya.raj@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Foundation for Innovative New Diagnostics India, Flat No. 6-14, 9th floor
Vijaya Building
17 Barakhamba Road
New Delhi 110001
India |
|
|
Primary Sponsor
|
| Name |
Foundation for Innovative New Diagnostics India |
| Address |
FIND India
Flat No. 6-14, 9th floor
Vijaya Building
17 Barakhamba Road
New Delhi 110001
India |
| Type of Sponsor |
Other [Not For Profit Organization] |
|
|
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 R Priya |
ICMR- National Institute for Research in Tuberculosis |
Ground Floor, Building No. 1, Mayor Sathiyamoorthy Road
Chetpet, Chennai – 600 031
India
Chennai
TAMIL NADU |
04428369660
priya.raj@icmr.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute for Research in Tuberculosis, Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FluoroType MTBDR V2 Assay |
The investigational product (FluoroType MTBDR V2 assay) are intended for the
detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis
mutations associated with resistance to Rifampicin and Isoniazid.
The Limit of Detection was determined by the manufacturer to be between 14 and 24 CFU/mL for TB detection. This is 1 log lower than what has been reported for Xpert MTB/RIF (131 CFU/mL).
Frequency : One time during Screening |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Aged Equal ore more than 18 years.
2) Clinical suspicion of pulmonary TB including productive cough of equal or more than 2 weeks and equal or more than 1 week for other symptom typical of pulmonary TB listed below:
2.1. Fever
2.2. Contact with active case
2.3. Malaise
2.4. Haemoptysis
2.5. Recent weight Loss
2.6. Chest Pain
2.7. Night sweats
2.8. Loss of appetite
3) Willing to Provide two sputum specimens at enrollment
4) Willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1) Only extra-pulmonary TB signs & symptoms
2) Receipt of any dose of TB treatment within 6 months prior to enrolment or currently on TB treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Diagnostic accuracy for MTB detection: clinical sensitivity
and specificity by smear-status measured against
mycobacterial culture as the reference standard. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Diagnostic accuracy for MTB detection:clinical point estimates of sensitivity and specificity measured against
mycobacterial culture as the reference standard by sub gr oup.
2) Operational characteristics - description of operator
experience with the assays through daily observed usage and user appraisal questionnaires |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
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)
|
22/08/2022 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cross-sectional diagnostic accuracy study with culture, phenotypic DST and sequencing as reference standards and Xpert MTB/RIF (or Ultra) as a comparator. Results from the FluoroType MTBDR V2 assay will not be used to make clinical decisions. Participants in whom pulmonary TB is suspected. Additionally, well-characterized RIF-resistant and INH-resistant samples will be used to supplement drug-resistant cases. The primary Objective is to Estimate diagnostic accuracy of FluoroType MTBDR V2 assay for MTB detection for smear-positive and smear negative TB, including Xpert MTB/RIF (or Ultra) as a comparator and culture as the reference standard and to Estimate diagnostic accuracy of FluoroType MTBDR V2 assay for resistance detection (RIF/INH) with sequencing and phenotypic DST as the reference standard. |