Using N-acetylcysteine to prevent lung disease after tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.