| CTRI Number |
CTRI/2025/04/085883 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational diagnostic accuracy study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess diagnostic accuracy of child friendly samples ( stool & tongue swabs) for diagnosing TB in children with TB symptoms
|
|
Scientific Title of Study
|
Enhance Tuberculosis Diagnosis and Improve Linkage to TB treatment in Indian Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kumar Mattoo MD DTCD |
| Designation |
Joint Commissioner (SAG Officer), Central TB Division, National TB Elimination Program, Ministry of HFW, Govt. of India, |
| Affiliation |
Central TB Division Government of India |
| Address |
Dr Sanjay Kumar Mattoo, MD , DTCD
Joint Commissioner (SAG Officer),
Central TB Division, National TB Elimination Program,
Ministry of HFW, Govt. of India,
Room no 204, Second Flr, Jeevan Vihar Building, Sansad Marg,
Connaught Place, New Delhi-110001
Central
DELHI
110001
India |
| Phone |
8076766625 |
| Fax |
|
| Email |
mattoos@rntcp.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar Mattoo MD DTCD |
| Designation |
Joint Commissioner (SAG Officer), Central TB Division, National TB Elimination Program, Ministry of HFW, Govt. of India, |
| Affiliation |
Central TB Division Government of India |
| Address |
Dr Sanjay Kumar Mattoo, MD , DTCD
Joint Commissioner (SAG Officer),
Central TB Division, National TB Elimination Program,
Ministry of HFW, Govt. of India,
Room no 204, Second Flr, Jeevan Vihar Building, Sansad Marg,
Connaught Place, New Delhi-110001
Central
DELHI
110001
India |
| Phone |
8076766625 |
| Fax |
|
| Email |
mattoos@rntcp.org |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar Mattoo MD DTCD |
| Designation |
Joint Commissioner (SAG Officer), Central TB Division, National TB Elimination Program, Ministry of HFW, Govt. of India, |
| Affiliation |
Central TB Division Government of India |
| Address |
Dr Sanjay Kumar Mattoo, MD , DTCD
Joint Commissioner (SAG Officer),
Central TB Division, National TB Elimination Program,
Ministry of HFW, Govt. of India,
Room no 204, Second Flr, Jeevan Vihar Building, Sansad Marg,
Connaught Place, New Delhi-110001
Central
DELHI
110001
India |
| Phone |
8076766625 |
| Fax |
|
| Email |
mattoos@rntcp.org |
|
|
Source of Monetary or Material Support
|
| Centers for Disease Control & Prevention(CDC) Embassy of the United States of America aShantipath, Chanakyapuri, New Delhi-110021 ( contact 011-24198000) |
|
|
Primary Sponsor
|
| Name |
Central TB Division NTEP |
| Address |
Jeevan Vihar building 3 Sansad Marg C P New Delhi 110011 |
| Type of Sponsor |
Other [Central TB Division NTEP] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SHARE INDIA |
MIMS Campus Ghanpur Village Medchal Malkagiri district Telangana 501401 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ira Shah |
Bai Jerbai Wadia Hospital and Research Centre |
Head of the department, GI & infectious disease, Second Floor Room No 204, Bai Jerbai Wadia Hospital and Research Centre Acharya Donde Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA |
9223437582
irashah@pediatriconcall.com |
| Dr Anurag Agarwal |
Department of Paediatrics Maulana Azad Medical College |
Prof. Dr. Anurag Agarwal
Professor, Pediatrics
Maulana Azad Medical College and
associated Lok Nayak Hospital, Delhi-110002
Central
DELHI |
9810409625
doctoranuragagarwal@gmail.com |
| Dr Lavanya J |
Institute of Child Health and Hospital for children |
Dr. Lavanya, MBBS, DTCD, Program Officer, First Floor, DTO room No 11, NTEP, Greater Chennai, Corporation, Halls Road Egmore Chennai 600008 Chennai -600008
Chennai
TAMIL NADU |
9486710299
dtotncni@rntcp.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madras Medical College Chennai 600003 |
Approved |
| Institutional Ethics Committee Maulana Azad Medical College |
Approved |
| Institutional Ethics Committee-Bai Jerbai Wadia Hospital For Children |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children with presumptive TB up to and including 18 years of age whose parents consent to providing their children’s samples for enhanced diagnosis during the designated project activity period |
|
| ExclusionCriteria |
| Details |
Children who received anti tubercular therapy (ATT) including second line drugs for more than 72 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of stool and tongue swab CBNAAT and Truenat positive among the presumptive TB children and Proportion of stool and tongue swab Xpert Ultra and Truenat Plus positive among the presumptive TB children
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| c. Sensitivity and specificity of stool and tongue swab for detection of TB among the presumptive TB children considering Mycobacterium Growth Indicator tube (MGIT) liquid culture as gold standard. |
15 months |
|
|
Target Sample Size
|
Total Sample Size="1700"
Sample Size from India="1700"
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)
|
30/05/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 an observational study with an aim to explore concurrence between standard methods and alternative methods to improve paediatric TB diagnosis through use of NAAT molecular diagnostic testing such as stool and tongue swab Child friendly samples i e stool and tongue swab samples will be tested using Xpert MTB/RIF Ultra to compare its performance with routine national diagnostic procedures As well stool and tongue swab samples will be tested by Truenat MTB Plus to determine non-inferiority in terms of sensitivity and specificity compared to Xpert MTB/RIF Ultra |