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CTRI Number  CTRI/2024/01/061453 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 13/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of longer vs shorter regimen for treatment of multi drug resistant tuberculosis 
Scientific Title of Study   Efficacy of longer regimen vs shorter regimen in Multi Drug Resistant tuberculosis treated under Programmatic Management of Drug Resistant Tuberculosis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwin Karnan 
Designation  Junior resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442005
India 
Phone  9360691315  
Fax    
Email  ashwin2700@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ulhas Jadhav 
Designation  Professor and head of unit 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442005
India 
Phone  9970819099  
Fax    
Email  drulhasjadhav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashwin Karnan 
Designation  Junior resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Flat no 6, Meghe Heights 1, Boys hostel, Jawaharlal Nehru Medical College campus, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442005
India 
Phone  9360691315  
Fax    
Email  ashwin2700@gmail.com  
 
Source of Monetary or Material Support  
National Tuberculosis Elimination Programme 
 
Primary Sponsor  
Name  JAWAHARLAL NEHRU MEDICAL COLLEGE  
Address  JAWAHARLAL NEHRU MEDICAL COLLEGE SAWANGI ( MEGHE ) WARDHA 442005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NTEP   THE DTO , DTC ,CIVIL HOSPITAL CAMPUS, WARDHA , MAHARASHTRA 442001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashwin Karnan  Acharya Vinobha Bhave Rural Hospital,   Ward no 37, Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe
Wardha
MAHARASHTRA 
9360691315

ashwin2700@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z163||Resistance to other antimicrobialdrugs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. All patients diagnosed with drug-resistant tuberculosis and are under treatment at Acharya Vinoba Bhave Rural Hospital
2. Patients more than 18 years of age 
 
ExclusionCriteria 
Details  Patients not giving consent  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Smear and sputum conversion will be studied in patients on longer regimen vs shorter regimen in multi drug resistant tuberculosis
2. culture negativity of bacteria with duration of treatment will be studied and compared between longer vs shorter regimen
3. clinical profile, adverse effects, drug compliance and outcome in patients will be studied in these two regimens
4. Any new outcome during the course of the study will be assessed  
8 weeks- 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To prepare best modality of treatment  2 years 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   24/01/2024 
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 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  

Tuberculosis (TB) is a communicable disease that is a major cause of ill health and one of the leading causes of death worldwide. It is caused by the bacillus Mycobacterium tuberculosis. Drug-resistant TB continues to be a public health threat. The Standard DR TB regimen under PMDT for MDR TB comprises of Shorter oral Bedaquilline containing regimen and a longer oral Bedaquilline containing regimen. The patients are screened based on various criteria and the patients eligible for shorter oral BDQ containing regimen are started on shorter regimen and the rest are started on longer regimen.

Shorter regimen comprises 9-12 months divided into 6 months of intensive phase (Lfx, Mfx, Cfz, Z, E, H(h), Eto) and 5 months of continuation phase (Lfx/Mfx, Cfz, Z, E).

Longer MDR TB regimen has a duration of 18 to 24 months. The drugs are divided into three groups A, B and C.  As per WHO 2020 recommendations all three Group A agents and at least one Group B agent should be included to ensure that the treatment starts with at least 4 drugs and at least 3 drugs are continued when Bdq is stopped. However, in India, the experts concurred to start with all 5 drugs of group A and B and continue with 4 drugs in the later part of the regimen.

 

This study aims to evaluate the efficacy of longer regimen vs shorter regimen in multi drug resistant tuberculosis. This study will be conducted in AVBRH, a tertiary care hospital, attached to Jawaharlal Nehru Medical College, situated in the rural area of Sawangi Meghe, Wardha in central India. All patients of Drug Resistant Tuberculosis attending the outpatient department(OPD)/admitted to the Inpatient department (IPD) of Respiratory Medicine Department and General Medicine Department AVBRH, Sawangi (Meghe) fulfilling the inclusion criteria will comprise study material.

 

All new MDR /XDR TB patients or MDR/XDR patients already under treatment from our institute will be taken for this study. Patients will be divided into two groups. One group will comprise patients on longer regimen and the second group will comprise patients on shorter regimen.

 

Follow up will be taken with monthly sputum smear examination from the third month and culture at the end of the third month, sixth month, ninth month, and/or end of treatment. Both groups will be compared for treatment outcome, drug compliance, and adverse effects.

 
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