Comparison of longer vs shorter regimen for treatment of multi drug resistant tuberculosis

Not yet recruiting

Conditions: Resistance to other antimicrobialdrugs,

Registration Number: CTRI/2024/01/061453

Lead Sponsor: JAWAHARLAL NEHRU MEDICAL COLLEGE

Brief Summary: Tuberculosis (TB) is acommunicable disease that is a major cause of ill health and one of the leadingcauses of death worldwide. It is caused by the bacillus Mycobacteriumtuberculosis. Drug-resistant TB continues to be a public health threat. The Standard DRTB regimen under PMDT for MDR TB comprises of **Shorter oral** **Bedaquillinecontaining regimen** and a **longer oral Bedaquilline containing regimen.** Thepatients are screened based on various criteria and the patients eligible for shorteroral BDQ containing regimen are started on shorter regimen and the rest are startedon longer regimen.

Shorter regimen comprises 9-12 months divided into6 months of intensive phase (Lfx, Mfx, Cfz, Z, E, H(h), Eto) and 5 months ofcontinuation 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 threeGroup A agents and at least one Group B agent should be included to ensure thatthe treatment starts with at least 4 drugs and at least 3 drugs are continuedwhen Bdq is stopped. However, in India, the experts concurred to start with all5 drugs of group A and B and continue with 4 drugs in the later part of theregimen.

This study aims to evaluate the efficacy of longerregimen vs shorter regimen in multi drug resistant tuberculosis. This studywill be conducted in AVBRH, a tertiary care hospital, attached to Jawaharlal NehruMedical College, situated in the rural area of Sawangi Meghe, Wardha in centralIndia. All patients of Drug Resistant Tuberculosisattending 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 patientsalready under treatment from our institute will be taken for this study.Patients will be divided into two groups. One group will comprise patientson longer regimen and the second group will comprise patients on shorterregimen.

Follow up will be taken with monthly sputum smear examination from thethird 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

Patients not giving consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Smear and sputum conversion will be studied in patients on longer regimen vs shorter regimen in multi drug resistant tuberculosis	8 weeks- 12 weeks
2. culture negativity of bacteria with duration of treatment will be studied and compared between longer vs shorter regimen	8 weeks- 12 weeks
4. Any new outcome during the course of the study will be assessed	8 weeks- 12 weeks
3. clinical profile, adverse effects, drug compliance and outcome in patients will be studied in these two regimens	8 weeks- 12 weeks

Secondary Outcome Measures

Name	Time	Method
To prepare best modality of treatment	2 years

Trial Locations

Locations (1): Acharya Vinobha Bhave Rural Hospital,
🇮🇳
Wardha, MAHARASHTRA, India
Acharya Vinobha Bhave Rural Hospital,
🇮🇳Wardha, MAHARASHTRA, India
Dr Ashwin Karnan
Principal investigator
9360691315
ashwin2700@gmail.com