Using N-acetylcysteine to prevent lung disease after tuberculosis
A Confirmatory Trial of Adjunctive N-acetylcysteine to Prevent Post Tuberculosis Lung Disease (NAC-PTLD) - A TB SEQUEL II Substudy
This study is testing if adding N-acetylcysteine to standard tuberculosis treatment can help prevent lung problems after TB for people at risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Aurum Institute NPC Academic / other |
| Locations | 1 site (Fajara, The Gambia) |
| Trial ID | NCT06909799 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of N-acetylcysteine (NAC) as an adjunctive therapy for patients with pulmonary tuberculosis who are at risk for post-tuberculosis lung disease (PTLD). Participants will receive either NAC along with standard TB treatment or standard TB treatment alone, and their lung function, respiratory symptoms, and quality of life will be monitored over 12 months. The study aims to determine if NAC can improve lung function and reduce the incidence of PTLD while assessing its safety. Researchers will conduct various assessments, including respiratory evaluations and blood tests, throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with severe pulmonary impairment due to pulmonary tuberculosis.
Not a fit: Patients with conditions that could compromise their well-being or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to prevent lung disease in patients recovering from tuberculosis.
How similar studies have performed: Previous studies have suggested that NAC may help mitigate lung impairment in tuberculosis patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 willing to start ART during study participation
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, such as pneumothorax or clinically significant pleural effusion
2. Pregnancy or breast-feeding
3. Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death during the trial or the follow-up period.
4. TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome as judged by the investigator.
5. History of allergy or hypersensitivity to any of the trial therapies or related substances, including known allergy or suspected hypersensitivity to rifampin.
6. Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.
7. No more than 5 days treatment for the current TB episode, and no other TB treatment in the preceding 6 months
8. Angina pectoris requiring treatment with nitroglycerin or other nitrates
9. Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator
10. Random blood glucose \>140 mg/dL (or \>7.8 mmol/L), or history of unstable Diabetes Mellitus which required hospitalization for hyper- or hypoglycaemia within the past year prior to start of screening.
11. Use of systemic corticosteroids within the past 28 days, or a likely to require corticosteroids for management of another medical condition during the period of study participation.
12. Patients requiring treatment with medications not compatible with rifampin, such as HIV protease inhibitors
13. Subjects with any of the following abnormal laboratory values:
1. creatinine \>2 mg/dL
2. haemoglobin \<8 g/dL
3. platelets \<100x109 cells/L
4. serum potassium \<3.5
5. aspartate aminotransferase (AST) ≥2.0 x ULN
6. alkaline phosphatase (AP) \>5.0 x ULN
7. total bilirubin \>1.5 mg/dL
8. positive HBsAg
Where this trial is running
Fajara, The Gambia
- MRC Unit The Gambia at LSHTM — Fajara, The Gambia, The Gambia (Recruiting)
Study contacts
- Principal investigator: Robert Wallis - Professor — Aurum Institute
- Study coordinator: Fadzai E Munedzimwe, MPH
- Email: FMunedzimwe@auruminstitute.org
- Phone: +27(0)0105901300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.