| CTRI Number |
CTRI/2025/12/098559 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Does the New Tuberculosis Treatment Work? Testing a Six-Month Medicine Combination in Indian Patients |
|
Scientific Title of Study
|
To Evaluate Efficacy and Safety of BPaLM Regimen in Drug-Resistant Tuberculosis Patients at a Tertiary Care Center in India: A Prospective
Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Singh Shekhawat |
| Designation |
Post Graduate Student |
| Affiliation |
B. P. S. Government Medical College For Women |
| Address |
3313, Department of Pharmacology, BPSGMC(W), Khanpur Kalan, Sonipat, Haryana
Sonipat HARYANA 131305 India |
| Phone |
8005929679 |
| Fax |
|
| Email |
shekhamayank@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Seema Rani |
| Designation |
Professor & Head |
| Affiliation |
B. P. S. Government Medical College For Women |
| Address |
3305, Department of Pharmacology, BPSGMC(W), Khanpur Kalan, Sonipat, Haryana
Sonipat HARYANA 131305 India |
| Phone |
9466359666 |
| Fax |
|
| Email |
seema17march@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mayank Singh Shekhawat |
| Designation |
Post Graduate Student |
| Affiliation |
B. P. S. Government Medical College For Women |
| Address |
3313, Department of Pharmacology, BPSGMC(W), Khanpur Kalan, Sonipat, Haryana
Sonipat HARYANA 131305 India |
| Phone |
8005929679 |
| Fax |
|
| Email |
shekhamayank@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Government Medcal College for Women |
| Address |
Khanpur Kalan, Sonipat
PIN - 131305 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Mayank Singh Shekhawat |
B. P. S. Government Medical College For Women |
Department of Respiratory Medicine Sonipat HARYANA |
8005929679
shekhamayank@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A157||Primary respiratory tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with age 14 years and above with microbiologically confirmed Drug-Resistant Tuberculosis (Rifampicin Resistant Tuberculosis/ Multi-drug Resistance Tuberculosis/ Extensive
Drug Resistance Tuberculosis).
2.Subjects who are willing to give written informed consent (assent where applicable).
3.H/o of Drug Exposure: Person with exposure of less than one month intake of Bedaquiline, Pretomanid and/ or Linezolid in the past.
or
Person with exposure of more than one month intake of Bedaquiline, Pretomanid and/ or Linezolid and documented sensitivity to these drugs.
or
Person who had not failed treatment with Bedaquiline or Linezolid containing shorter or longer regimen, and sensitivity to these drugs is documented. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy Parameters - Final Treatment Outcome, Sputum Culture Conversion, Time to Culture Conversion
Safety Parameters - Type of ADRs, Frequency of ADRs, Severity of ADRs |
Efficacy Parameters - Weeks 8, 12, 16, 20 and 26(End of Treatment)
Safety Assessment - Weeks 2, 4, 8, 12, 16, 20, and 26 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adherence Parameters – Missed Doses, Default Episodes, Reasons for Missed Doses
Quality of Life Parameters - Physical Health, Psychological Health, Social Relationships, Environment |
Adherence Assessment - Weeks 2, 4, 8, 12, 16, 20, and 26
Quality of Life Assessment – On Enrolment and End of Treatment (Week 26) |
|
|
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)
|
18/12/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Tuberculosis (TB) is an infectious disease caused by the bacteria Mycobacterium tuberculosis. It mainly affects the lungs and spreads from person to person through the air. Common symptoms of pulmonary tuberculosis include a prolonged cough, chest pain, weakness or fatigue, weight loss, fever, and night sweats. Significant efforts have been made to control and eliminate TB, which is treatable with a standard short course of therapy. However, the emergence of drug resistance is a major threat to global efforts to end TB. The BPaLM (Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin) regimen represents a significant advancement in DR-TB (Rifampicin-Resistant Tuberculosis/Multi-Drug Resistant Tuberculosis/Extensively Drug-Resistant Tuberculosis) treatment, offering a 6-month, all-oral medication with the potential for improved outcomes and patient experience compared to conventional longer regimens. In spite of the promising results from clinical trials, there are still gaps in our understanding of the real-world effectiveness and safety of the BPaLM regimen, notably in diverse settings with varying healthcare infrastructures and patient populations. This study aims to meticulously collect data on treatment adherence, adverse events, culture conversion, and final treatment outcomes, which might not be consistently captured in routine programmatic data. As there is a scarcity of efficacy and safety data on the components of the BPaLM regimen in the Indian population. Therefore, by filling this critical knowledge gap, the study will contribute to the improvement of global and national TB programmes. An adequate number of subjects will be screened and selected as per the inclusion and exclusion criteria of the study after approval from the Institutional Ethics Committee (IEC), UHS Rohtak will be enrolled. A patient information sheet will be provided to every eligible subject for the study, and thereafter, an informed written consent and assent, if applicable, will be taken from the subjects of this study. The subject’s details will be recorded in the case record form. At the beginning of the study, all subjects confirmed as DR-TB will undergo a detailed history (smoking, comorbidities, h/o previous TB treatment, use of other medications, substance abuse), clinical examination, and systemic examination, and relevant investigations, including CBC, LFT, and renal function, will be enrolled for the study. |