Health Condition 1: null- Pulmonary Tuberculosis Health Condition 2: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Metformin, Isoniazid, Rifampicin, Ethambutol, Pyrazinamide: Intervention arm : Metformin + Isoniazid + Rifampicin + Ethambutol + Pyrazinamide
Control Intervention1: Isoniazid, Rifampic
Sponsors
National Institute for Research in Tuberculosis
Open Source Pharma Foundation
Eligibility
Inclusion criteria
Inclusion criteria: A patient will be eligible for entry to the trial if ALL the following conditions are satisfied 1. Male or female, aged 18 years or over. 2. Willing to give written informed consent 3. Body weight >= 30 kg and 4. At least 2 sputum smears should be positive for TB bacilli 5. At least 1 sputum should be RMP /INH sensitive by Gene Xpert /LPA 6. No prior history of ATT (i.e. 7. Is willing to have an HIV test. 8. Agrees to use effective barrier contraception during the period of the trial 9. Residing in and around the study sites of Chennai / Vellore / Madurai / Delhi / Pune and 10.Express willingness to attend the treatment center for supervised treatment 11. Express willingness to adhere to the trial procedures and follow-up schedule
Exclusion criteria
Exclusion criteria: A Patient will not be eligible for the trial if they meet ANY of the following criteria 1. Body weight 65 kgs 2. Has history of previous anti-TB treatment (more than a month). 3. Is infected with a strain of M tb resistant to rifampicin, and pyrazinamide by indirect susceptibility test in liquid culture. 4. Has clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis). 5. Is of poor general condition where any delay in treatment could not be tolerated (Karnofsky scale 6. Has any evidence of renal impairment, including but not limited to serum creatinine levels above the upper limit of the laboratory reference range (Serum creatinine >1.2 mg/dL or blood yrea >43 mg/dL) 7. Has clinical icterus or hepatic impairment characterized by serum bilirubin level above 1.2 times upper limit of the laboratory reference range, or by alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) levels >3 times the upper limit of the laboratory reference range 8. Psychiatric illness 9. Serology positive for HBS Ag or Hepatitis C virus antibody 10. Is pregnant or lactating 11. Known case of Diabetes mellitus /RBS > 200mg/dl /FBS >140 mg/dl 12. Has a history and/ or presence (or evidence) of neuropathy or Epilepsy. 13. Has any condition (social or medical) which in the opinion of the investigator would make trial participation unreliable or unsafe. 14. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements 15. Has a known allergy to any of the drugs proposed to be used in the trial regimen 16. Has evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the time to sputum culture conversion.Timepoint: 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Drug concentrations and pharmacokinetic parameters of R, H, Z and MET in adults with pulmonary TB patients receiving MET with standard first-line ATT 2.Measurement of biomarkers and immune responses for the impact of MET on TB disease activity 3.Median time to detection (TTD) of M.tb in culture through 8 weeks of therapy between those receiving MET containing ATT regimen and the standard ATT 4. Treatment Emergent Adverse Events Timepoint: At 1, 2, 3, 4, 5, 6, 7 & 8 weeks after randomization. | — |
Countries
India
Contacts
Public ContactDr C Padmapriyadarsini
National Institute for Research in Tuberculosis [ICMR]
Outcome results
None listed