Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Delamanid: Tablet delamanid 100 mg twice daily, taken by orally for 6 months
Control Intervention1: No comparator is present: The present study is observational study only
Sponsors
Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh
Eligibility
Inclusion criteria
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
Exclusion criteria: 1.Serum albumin: 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) 10.Karnofsky score 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECG evaluationTimepoint: At 3 months & 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| QTc INTERVALTimepoint: At 3 months & 6 months | — |
Countries
India
Contacts
Public ContactDr Pratik vijay ganvir
JNMCH, AUM, Aligarh
Outcome results
None listed