| CTRI Number |
CTRI/2024/09/073821 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of pooling of gastric aspirate contents(3 samples mixed together) for increased yield in diagnosis of Tuberculosis in children through NAAT(diagnostic test). |
|
Scientific Title of Study
|
Utility of pooling of Gastric Aspirate for Nucleic Acid Amplification Test in Diagnosis of suspected cases of Pulmonary Tuberculosis in 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 Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical college and Associated Lok Nayak Hospital |
| Address |
Department of Pediatrics,
Maulana Azad Medical college and Associated Lok Nayak Hospital,
New Delhi,
Delhi,
110002,
India.
New Delhi
DELHI
11002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical college and Associated Lok Nayak Hospital |
| Address |
Department of Pediatrics,
Maulana Azad Medical college and Associated Lok Nayak Hospital,
New Delhi,
Delhi,
110002,
India.
DELHI
11002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Omkar Doiphode |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical college and Associated Lok Nayak Hospital |
| Address |
Department of Pediatrics,
Maulana Azad Medical college and Associated Lok Nayak Hospital,
New Delhi,
Delhi,
110002,
India.
New Delhi
DELHI
110002
India |
| Phone |
8369954901 |
| Fax |
|
| Email |
doiphodeomkar72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, Maulana Azad Medical college,Delhi-110002,India. |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics |
| Address |
Maulana Azad Medical College, New Delhi-110002,India. |
| Type of Sponsor |
Government medical college |
|
|
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 Omkar Doiphode |
Lok Nayak Hospital |
Room no.516,Pediatrics OPD, Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
Delhi
New Delhi
DELHI |
8369954901
doiphodeomkar72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A159||Respiratory tuberculosis unspecified, (2) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Suspected cases of pulmonary Tuberculosis according to National Tuberculosis Elimination Program guidelines(2022). |
|
| ExclusionCriteria |
| Details |
Children who received Antitubercular Therapy for more than 7 days.
Children who can expectorate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nucleic acid amplification test (NAAT) positives as a proportion of suspected/culture confirmed cases of pulmonary tuberculosis on 3-Day Pooled Gastric aspirate (GA). |
Day 1 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Sensitivity, specificity, Positive Predictive Value & Negative Predictive Value of NAAT on 3-Day pooled Gastric aspirate as compared to MGIT.
2. Sensitivity, specificity, Positive Predictive Value & Negative Predictive Value of NAAT on a single (Day-1) Gastric aspirate as compared to MGIT.
|
Day 1 & Day 3 |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
25/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To increase the diagnostic yield of detecting pulmonary tuberculosis in pediatric population by pooling 3 morning samples of gastric aspirate for nucleic acid amplification testing as bacilli causing the disease are proven to shed in the secretions over distributed time periods. |