Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: N-Acetyl Cysteine: Tablets, 600 mg twice daily for six months
Control Intervention1: None: None
Sponsors
Dr Saurabh Mittal
Dr Anant Mohan
Dr Karan Madan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or more. 2. Willing to give written informed consent. 3. Body weight = 30 kg. 4. Pulmonary TB diagnosed with One sputum OR Bronchoalveolar lavage GeneXpert test positive. 5. No detection of Rifampicin resistance by GeneXpert/ LPA/ MGIT C/S. 6. A chest radiograph abnormality consistent with tuberculosis. 7. No prior history of ATT. 8. Willing to undergo HIV serology testing. 9. Agrees to use effective barrier contraception during the period of the study. 10. Residing around the study site (AIIMS, Delhi). 11. Express willingness to attend the treatment center for supervised treatment. 12. Express willingness to adhere to the trial procedures and follow-up schedule.
Exclusion criteria
Exclusion criteria: 1. Clinically significant evidence of extrapulmonary TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis). 2. Poor general condition as assessed by the study investigator. 3. Renal dysfunction 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 urea >43 mg/dL) 4. Has clinical jaundice 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 5. Diabetes mellitus or Psychiatric illness 6. Serology positive for HBSAg Or Hepatitis C virus antibody Or HIV 7. Pregnant or lactating females 8. Has any condition (social or medical) which in the opinion of the investigator would make trial participation unreliable or unsafe 9. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 10. Has a known allergy to any of the drugs proposed to be used in the trial regimen 11. Has evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in pre-bronchodilator FVC and FEV1 between the two groups at 2 months from baselineTimepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in pre-bronchodilator FVC and FEV1 between the two groups at 6 monthsTimepoint: 6 months;The number of adverse events between the NAC containing arm and control arm during 6 months of therapyTimepoint: 6 months;The proportion of patients having “unfavorable outcome ? at 6 months (defined as composite of radiologically active disease, sputum culture positive, death due to tuberculosis and NAC discontinuation)Timepoint: 6 months;The proportion of patients having IGRA positivity at the end of 6 monthsTimepoint: 6 months;The proportion of patients having radiological improvement/stabilisation at two months and six monthsTimepoint: 2 months and 6 months;The proportion of patients having sputum/ BAL culture negativity at two weeksTimepoint: Two weeks;To compare the change in biomarkers of oxidative stress & inflammation at 2 month between NAC containing arm and the control armTimepoint: 2 months | — |
Countries
India
Contacts
Public ContactSaurabh Mittal
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed