跳至主要内容
临床试验/CTRI/2024/01/061453
CTRI/2024/01/061453尚未招募不适用

Efficacy of longer regimen vs shorter regimen in Multi Drug Resistant tuberculosis treated under Programmatic Management of Drug Resistant Tuberculosis

JAWAHARLAL NEHRU MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
1. Smear and sputum conversion will be studied in patients on longer regimen vs shorter regimen in multi drug resistant tuberculosis

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients diagnosed with drug-resistant tuberculosis and are under treatment at Acharya Vinoba Bhave Rural Hospital
  • Patients more than 18 years of age.

排除标准

  • Patients not giving consent.

结局指标

主要结局

1. Smear and sputum conversion will be studied in patients on longer regimen vs shorter regimen in multi drug resistant tuberculosis

时间窗: 8 weeks- 12 weeks

2. culture negativity of bacteria with duration of treatment will be studied and compared between longer vs shorter regimen

时间窗: 8 weeks- 12 weeks

4. Any new outcome during the course of the study will be assessed

时间窗: 8 weeks- 12 weeks

3. clinical profile, adverse effects, drug compliance and outcome in patients will be studied in these two regimens

时间窗: 8 weeks- 12 weeks

次要结局

  • To prepare best modality of treatment(2 years)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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