To find out safety and efficacy of Delamanid in patient having resistance to multiple drugs used in Tuberculosis

Not Applicable

• Conditions: Health Condition 1: A150- Tuberculosis of lung

• Registration Number: CTRI/2023/08/056974
• Lead Sponsor: Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients capable of giving written informed consent

2.Diagnosis of MDR-TB on CBNAAT or sputum culture

3.Chest radiograph diagnostic of TB

4.Positive sputum sample

5.Normal ECG

Exclusion Criteria

1.Serum albumin: < 2.8g/dL

2.Patient on drug of strong inducer of CYP3A4 enzyme

3.Severe renal impairment

4.Moderate or severe hepatic impairment

5.Hypersensitivity to drug

6.Infection by Mycobacterial species other than those of the mycobacterium complex

7.Abnormal ECG and QTc

9.Body mass index (BMI) < 16 kg/m2

10.Karnofsky score < 50%

11.Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy

12.History of alcohol abuse

13.Pregnant, breast-feeding or planning to conceive

14.Previous exposure to Delamanid

Study & Design

• Study Type: Interventional
• Study Design: Not specified