A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
The goal of this clinical trial is to evaluate if N-acetylcysteine (NAC) works to prevent post-tuberculosis lung disease (PTLD) in patients with severe pulmonary impairment. It also aims to assess the safety of NAC. The main questions the study aims to answer are: Does NAC improve lung function (FEV1%) over 12 months i
| Condition(s) | Tuberculosis (TB) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to evaluate if N-acetylcysteine (NAC) works to prevent post-tuberculosis lung disease (PTLD) in patients with severe pulmonary impairment. It also aims to assess the safety of NAC. The main questions the study aims to answer are: Does NAC improve lung function (FEV1%) over 12 months in participants with pulmonary tuberculosis and baseline risk factors for PTLD? What medical issues or adverse events do participants experience while taking NAC? Researchers will compare NAC treatment to a control group to see if it can prevent PTLD when given in addition to standard TB treatment. Participants will: Take NAC (1800mg twice daily) for 6 months with standard TB treatment or receive standard TB treatment alone; Attend scheduled clinic visits for 12 months, during |
| Who can participate | Inclusion Criteria: 1. Persons aged 18 to 65 years 2. Willing and able to provide signed written consent, or witnessed oral con-sent with thumbprint in the case of illiteracy, prior to undertaking any trial-related procedures. 3. Body weight (in light clothing without shoes) between 30 and 90 kg. 4. Xpert TB/RIF OR Ultra showing RIF-S-MTB, with subsequent confirmation of MTB by culture. 5. Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis 1 6. FEV1 ≤65% of predicted adjusted for age, height, sex, and race 7. If female, of child-bearing potential and sexually active, willing to use a contraceptive method for the duration of study participation 8. HIV-1/2 seronegative, or if seropositive: CD4 T cell count ≥100/mcL and either currently receiving ART or will |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | The Aurum Institute NPC |
| Locations | Fajara, The Gambia, The Gambia |
| Start date | 2025-04-28 |
| NCT ID | NCT06909799 |
| Official listing | https://clinicaltrials.gov/study/NCT06909799 |