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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  
NIL 
 
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  
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 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.

 
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