Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: NAC (N- Acetyl Cysteine): Along with standard ATT, NAC will be given at a dose of 1200 mg twice daily, also for 6 months.NAC will be provided as 600mg capsules from NOW Foods, as was do
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years 2.Willing and able to provide signed written consent prior to undertaking any trial-related procedures. Or, in the case of illiteracy, witnessed oral consent plus patient thumbprint. 3.Body weight (in light clothing without shoes) between 30 and 90 kg. 4.Radiographic evidence of pulmonary tuberculosis 5.Positive Xpert TB RIF (original or Ultra) for MTB. 6.RIF susceptibility diagnosed by Xpert TB RIF, with subsequent culture confirmation 7.Eligible for treatment with a 6-month regimen comprised of INH, RIF, EMB, and PZA. 8.FEV1 less than or equal to 65 percent of predicted 9.Willing to use effective contraception for the first 9 months of study participation 10.HIV-1 seronegative, or if HIV-1 seropositive: presenting at a non-India study site with CD4 T cell count less than or equal to 100 per l and either receiving ART or willing to start ART during study participation 11.SARS-CoV-2 PCR or antigen test negative, or if positive, either fully vaccinated against Covid-19 (having had the full primary series of 1-2 doses according to approved schedules) or with D-dimer less than 1 g per ml
Exclusion criteria
Exclusion criteria: 1.Any condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments 2.Currently pregnant or nursing. 3.Is critically ill. 4.TB meningitis or spondylitis, or other forms of severe tuberculosis 5.History of allergy or hypersensitivity to any of the trial therapies or related substances. 6.History of a chronic lung condition (including COPD or asthma) requiring treatment in the previous year 7.Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial. 8.Prior TB treatment in the preceding 6 months, other than within the 7 days immediately prior to enrollment. 9.Angina pectoris requiring treatment with nitroglycerin or other nitrates 10.Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator 11.History of Diabetes Mellitus requiring metformin treatment or resulting in hospitalization for hyper- or hypoglycemia within the past year prior to start of screening. 12.Use of systemic corticosteroids within the past 28 days. 13.Patients requiring treatment with medications not compatible with rifampin, such as HIV-1 pro-tease inhibitors 14.History of Pneumoconiosis 15.Subjects with any of the following abnormal laboratory values: a. creatinine greater than2 mg per dL b. haemoglobin less than 8 g per dL c. platelets less than 100x109 cells per L d. serum potassium less than 3.5 mM per L e. alanine aminotransferase (ALT) less than or equal to 2.0 x ULN f. alkaline phosphatase (AP) greater than 5.0 x ULN g. total bilirubin greater than 1.5 mg per dL h. HbA1c of greater than 6.5 percent will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 at month 18, after adjustment for baseline covariates including FEV1, in a superiority comparison The proportion of patients achieving a satisfactory (favourable)outcome assessed at month 18 (12 months post-End of treatment[EOT]), after ad-justment for baseline covariates, in a non-inferiority comparison, with supe-riority testing to follow if NI is determined Timepoint: At month 18 (12 months post-End of treatment[EOT]) | — |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 and FVC modelled throughout the study period by linear mixed effects modelling. The hazard ratio for stable culture conversion (HR SCC) through the 6th month of treatment. The proportion of subjects with TE ALT increases, graded according to se-verityTimepoint: At 18 month | — |
Countries
India
Contacts
Public ContactDr PK Bhavani
ICMR - National Institute for Research in Tuberculosis (NIRT)
Outcome results
None listed