| CTRI Number |
CTRI/2019/07/020139 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
10/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
To estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH resistance detection |
| Study Design |
Other |
|
Public Title of Study
|
Gene Xpert XDR-TB Kit Evaluation |
|
Scientific Title of Study
|
Phase II : Multicentre clinical study to assess the performance of the Xpert MTB/XDR Assay for INH and Second Line Resistance Detection Xpert MTB/XDR Clinical Evaluation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03728725 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vithal Prasad Myneedu |
| Designation |
Microbiologist SAG |
| Affiliation |
National Institute of TB and Respiratory Diseases |
| Address |
Sri Aurobindo Marg Near Qutub Minar
South
DELHI
110030
India |
| Phone |
9871102482 |
| Fax |
01126517834 |
| Email |
v.myneedu@nitrd.nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vithal Prasad Myneedu |
| Designation |
Microbiologist SAG |
| Affiliation |
National Institute of TB and Respiratory Diseases |
| Address |
Sri Aurobindo Marg Near Qutub Minar
South
DELHI
110030
India |
| Phone |
9871102482 |
| Fax |
01126517834 |
| Email |
v.myneedu@nitrd.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vithal Prasad Myneedu |
| Designation |
Microbiologist SAG |
| Affiliation |
National Institute of TB and Respiratory Diseases |
| Address |
Sri Aurobindo Marg Near Qutub Minar
South
DELHI
110030
India |
| Phone |
9871102482 |
| Fax |
01126517834 |
| Email |
v.myneedu@nitrd.nic.in |
|
|
Source of Monetary or Material Support
|
| Foundation for Innovative New Diagnostics India,Flat#8& 9th floor, vijaya building,17, Barakhamba road,New Delhi 11001 |
|
|
Primary Sponsor
|
| Name |
Foundation for Innovative New Diagnostics India |
| Address |
9th Floor Vijaya Building
17 Barakhamba Road New Delhi 110001 |
| Type of Sponsor |
Other [NGO Partner with RNTCP of India] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India
South Africa |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Camilla Rodrigues |
Hinduja Hospital |
Hinduja Hospital Research Centre Mumbai
Mumbai
MAHARASHTRA |
02224447785
dr_crodrigues@hindujahospital.com |
| Dr Vithal Prasad Myneedu |
National Institute of TB and Respiratory Diseases |
Sri Aurobindo Marg Near Qutub Minar
South
DELHI |
9871102482
01126517834
v.myneedu@nitrd.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee National Institute of TB and Respiratory Diseases |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J708||Respiratory conditions due to other specified external agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Second Line Line Probe Assay MTBDRSl Version 2 and Liquid Culture DST |
Diagnostic evaluation will be done in comparison with the existing diagnostic modalities of XDR-TB |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years and above
Symptoms suggesting pulmonary TB
Previously received more than 1 month of treatment for prior TB episode
Failing TB treatment with positive smear or culture after three months of standard treatment
Close contact with drug resistant TB case
Newly diagnosed with MDRTB within the last 30 days
Previously diagnosed with MDRTB and failed TB treatment with positive sputum or culture after three months of standard MDRTB treatment
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if informed consent is not provided |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of Xpert MTB/XDR assay for INH and Second Line resistance detection as a rapid diagnostic modality for XDRTB |
Diagnostic accuracy of Xpert MTB/XDR assay for INH and Second Line resistance detection as a rapid diagnostic modality for XDRTB at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Direct performance versus performance on cultured samples
Performance between sites
Performance by smear result
Performance by Gene target
Performance compared to Hain MTBDRplus/sl
Performance by patient HIV status
Performance by patient pre-treatment status
Performance as reflex test to Ultra or MTB/RIF assay |
9 months |
|
|
Target Sample Size
|
Total Sample Size="858"
Sample Size from India="350"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Awaiting approvals from HMSC |