CTRI Number |
CTRI/2023/04/052146 [Registered on: 28/04/2023] Trial Registered Prospectively |
Last Modified On: |
12/04/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare number of healthy household contacts aged between 6 to 18 years developing TB disease with tor without TB prophylactic therapy. |
Scientific Title of Study
|
Effectiveness of Tuberculosis Preventive Therapy on Healthy Household Contact- An Open Label Randomised Controlled Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Poulomi Roy |
Designation |
Junior Resident |
Affiliation |
Eras Lucknow Medical College and Hospital |
Address |
Department of Pediatrics, 2nd floor,Eras Lucknow Medical College and Hospital, Lucknow
Lucknow UTTAR PRADESH 2266003 India |
Phone |
8599825218 |
Fax |
|
Email |
poulomiroy29@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Geetika Srivastave |
Designation |
Professor |
Affiliation |
Eras Lucknow Medical College and Hospital |
Address |
Department of Pediatrics, 2nd floor, Eras Lucknow Medical College and Hospital, Lucknow
Lucknow UTTAR PRADESH 2266003 India |
Phone |
9721066555 |
Fax |
|
Email |
geetikasri@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Poulomi Roy |
Designation |
Junior Resident |
Affiliation |
Eras Lucknow Medical College and Hospital |
Address |
Department of Pediatrics, 2nd floor, Eras Lucknow Medical College and Hospital, Lucknow
Lucknow UTTAR PRADESH 2266003 India |
Phone |
8599825218 |
Fax |
|
Email |
poulomiroy29@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Dr Poulomi Roy |
Address |
Eras Lucknow Medical College and Hospital, Lucknow |
Type of Sponsor |
Other [Other (self)] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
POULOMI ROY |
Era Lucknow Medical College and Hospital |
IPD, Department of Pediatrics, 3rd Floor, Eras Lucknow Medical College Lucknow UTTAR PRADESH |
8599825218
poulomiroy29@gmail.com |
Dr Poulomi Roy |
Eras Lucknow Medical College and Hospital |
OPD,Department of Pediatics, 1st floor, Eras Lucknow Medical College and Hospital Lucknow Lucknow UTTAR PRADESH |
8599825218
poulomiroy29@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee eras Lucknow medical college |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
children 6-18 years, who are healthy household contacts of people with bacteriologically confirmed TB |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Healthy contacts receiving preventive therapy |
Healthy contacts receiving 6 months of isoniazid @10mg/kg/dose as preventive therapy |
Comparator Agent |
Healthy Household Contacts not receiving treatment |
No signs of TB infection or disease and will not be given any preventive therapy |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
Children 6-18 years of age who are healthy household contacts of people with bacteriologically confirmed pulmonary TB |
|
ExclusionCriteria |
Details |
Children in contact with adults having Multidrug resistant TB or Extensively drug resistant TB |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
We will compare the proportion of healthy household contacts aged 6-18 years developing TB over 9 months after receiving 6 months INH vs no TB preventive therapy |
Baseline, 2 weeks, 2 months, 4 months, 6 months and 9 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
we will compare the proportion of healthy household contacts developing TBI |
9 MONTHS |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
31/03/2024 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Effectiveness of Tuberculosis Preventive Therapy on Healthy Household contact |