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
|
|
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. |