| CTRI Number |
CTRI/2024/10/074969 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How common extra-pulmonary tuberculosis is in kids who are admitted to a rural hospital. |
|
Scientific Title of Study
|
Prevalence of Extra-Pulmonary Tuberculosis in children admitted In rural hospital. |
| 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.DINESH V HINGE |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
DMIHER,SAWANGI(M) |
| Address |
DEPT OF PEDIATRICS, JNMC,DHMIHER,SAWANGI(M),WARDHA
DEPT OF PEDIATRICS, JNMC,DHMIHER,SAWANGI(M),WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9665838726 |
| Fax |
|
| Email |
DINESHHINGEMGIMS@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.AMAR TAKSANDE |
| Designation |
PROFFESOR and HEAD |
| Affiliation |
DHMIHER,SAWANGI(M) |
| Address |
DEPT OF PEDIATRICS, JNMC,DHMIHER,SAWANGI(M),WARDHA
DEPT OF PEDIATRICS, JNMC,DHMIHER,SAWANGI(M),WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9665838726 |
| Fax |
|
| Email |
amar.taksande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRDINESH V HINGE |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
DHMIHER,SAWANGI(M) |
| Address |
DEPT OF PEDIATRICS, JNMC,DHMIHER,SAWANGI(M),WARDHA
DEPT OF PEDIATRICS, JNMC,DHMIHER,SAWANGI(M),WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9665838726 |
| Fax |
|
| Email |
DINESHHINGEMGIMS@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| THE TUBERCULOSIS ASSOCIATION OF INDIA,3, Cross road, New Delhi-11001, india |
|
|
Primary Sponsor
|
| Name |
THE TUBERCULOSIS ASSOCIATION OF INDIA |
| Address |
3, RED CROSS ROAD,NEW DELHI110001 |
| 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 |
| DRDINESH HINGE |
Acharya Vinoba Bhave Rural Hospital |
DEPT OF PEDIATRICS,JNMC,SAWNFI MEGHE, DMIHER
Wardha
MAHARASHTRA |
9665838726
DINESHHINGEMGIMS@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIHER INSTITUTIONAL Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A188||Tuberculosis of other specified organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Who had confirmed Extrapulmonary Tuberculosis bacteriologically.
clinically diagnosed Extrapulmonary Tuberculosis. |
|
| ExclusionCriteria |
| Details |
less than 1 months and more than 18 years.
known case of Pulmonary Tuberculosis on treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of extra pulmonary TB
Type of TB treatment
length of therapy (months)
complication of treatment
Complications secondary to TB (yes/no)
site of complications
hospitalization frequency
length of hospital stay |
at baseline or at first contact with patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| demographic characteristics of EPTB, Risk factors of EPTB in children. Correlation of the Truenett/CBNAAT & EPTB in children.Outcome of EPTB. |
30 DAYS OR before discharge |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
01/11/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [DINESHHINGEMGIMS@GMAIL.COM].
- For how long will this data be available start date provided 03-10-2024 and end date provided 03-10-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Prevalence of EPTB in children in rural hospital. To illustrate the demographic characteristics of EPTB . Risk factors of EPTB in children. Correlation of the Truenett/CBNAAT and EPTB in children. Outcome of the EPTB in children.
|