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CTRI Number  CTRI/2025/12/099038 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 14/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the efficacy of 3 months Isoniazid Rifampicin drug therapy versus 3 months Isoniazid Rifapentine drug therapy for children suffering from Tuberculosis Infection  
Scientific Title of Study   Comparison of efficacy of 3 months Isoniazid Rifampicin versus 3 months Isoniazid Rifapentine therapy for children suffering from Tuberculosis Infection A Randomised Open Label Controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sayed Bilal Abbas Rizvi 
Designation  Junior Resident 
Affiliation  Era Medical College 
Address  Department of paediatrics 2nd floor Room no 12 Era medical college and hospital Sarfaraz ganj

Lucknow
UTTAR PRADESH
226003
India 
Phone  8090934931  
Fax    
Email  bilalabbas92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sayed Bilal Abbas Rizvi 
Designation  Junior Resident 
Affiliation  Era Medical College 
Address  Department of paediatrics 2nd floor Room no 12 Era medical college and hospital Sarfaraz ganj

Lucknow
UTTAR PRADESH
226003
India 
Phone  8090934931  
Fax    
Email  bilalabbas92@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sayed Bilal Abbas Rizvi 
Designation  Junior Resident 
Affiliation  Era Medical College 
Address  Department of paediatrics 2nd floor Room no 12 Era medical college and hospital Sarfaraz ganj

Lucknow
UTTAR PRADESH
226003
India 
Phone  8090934931  
Fax    
Email  bilalabbas92@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Sayed Bilal Abbas Rizvi 
Address  Department of paediatrics 2nd floor Room no 12 Era medical college and hospital Sarfaraz ganj, pincode-226003 Lucknow 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sayed Bilal Abbas Rizvi  Era Medical College and Hospital  Department of paediatrics 2nd floor Room no 12 Sarfaraz ganj
Lucknow
UTTAR PRADESH 		 08090934931

bilalabbas92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Isoniazid Rifampicin  Patient who are diagnosed as tubercular infection will recieve Isoniazid Rifampicin once daily orally for 3months 
Intervention  Isoniazid Rifapentine   Patient who are diagnosed as tubercular infection will recieve Isoniazid Rifapentine once weekly orally for 3months. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  children of 2 years to less than 18years of both gendder who are contact of adult pulmonary TB patient who have TB infection. 
 
ExclusionCriteria 
Details  Children who are tuberculosis positive.
Children who are on steriod therapy(in last 2months).
Children who are chronically ill(nephrotyic syndrome, asthma, chronic diarrhea).
Children who reside more than 10km from DOT centre. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To find out the number of children with TB infection who remain disease free till six months after Isoniazid and Rifampicin or Isoniazid and Rifapentine therapy for 3 months.
To compare compliance rate of the two combination medications in these children. 		 6months
6months 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse drug reactions of the two combination medications.  6months 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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 4 
Date of First Enrollment (India)   31/12/2025 
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="2"
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 - NO
Brief Summary  

After fulfilling the inclusion and  exclusion criteria 128 patient will be selected and then they will be randomised by computer generated random table and allotment and concealment of subject will be done by using snose technique and then one group will recieve Isoniazid Rifampicin and the other group will recieve Isoniazid Rifapentine and then we will compare the efficacy of the two drug and compare compliance rate of the two combination medications in these children and compare adverse drug reactions  the two combination medications in these  children.

 
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