Actively Recruiting
A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
Led by The Aurum Institute NPC · Updated on 2025-04-30
242
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
T
The Aurum Institute NPC
Lead Sponsor
L
Ludwig-Maximilians - University of Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 which they will have respiratory assessments, blood tests, and symptom monitoring; Complete quality-of-life questionnaires and provide sputum and blood samples for analysis at multiple time points.
CONDITIONS
Official Title
A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persons aged 18 to 65 years
- Willing and able to provide signed written consent or witnessed oral consent if illiterate
- Body weight between 30 and 90 kg
- Positive Xpert TB/RIF or Ultra test showing rifampin-sensitive Mycobacterium tuberculosis confirmed by culture
- Chest X-ray showing moderate or far advanced pulmonary tuberculosis
- FEV1 of 65% or less of predicted adjusted for age, height, sex, and race
- For sexually active females of child-bearing potential, willingness to use contraception during study
- HIV negative, or if positive, CD4 count of at least 100/mcL and currently on or willing to start antiretroviral therapy
You will not qualify if you...
- Any condition that could compromise participant safety or affect study assessments, such as pneumothorax or significant pleural effusion
- Pregnancy or breastfeeding
- Critically ill with expected death during the trial or follow-up
- Tuberculous meningitis or other severe forms of tuberculosis with high risk of poor outcome
- Known allergy or sensitivity to study drugs including rifampin
- Participation in other investigational drug trials within 8 weeks prior or currently enrolled in another trial
- More than 5 days of treatment for current TB episode or any TB treatment in past 6 months
- Angina pectoris requiring nitrates
- Cardiac arrhythmia requiring medication or significant ECG abnormalities
- Random blood glucose over 140 mg/dL or history of unstable diabetes requiring hospitalization in past year
- Use of systemic corticosteroids in past 28 days or expected need during study
- Use of medications incompatible with rifampin such as HIV protease inhibitors
- Abnormal laboratory values including: creatinine >2 mg/dL, hemoglobin <8 g/dL, platelets <100x10^9/L, serum potassium <3.5, AST over twice upper limit normal, alkaline phosphatase over 5 times upper limit, total bilirubin over 1.5 mg/dL, or positive hepatitis B surface antigen
AI-Screening
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Trial Site Locations
Total: 1 location
1
MRC Unit The Gambia at LSHTM
Fajara, The Gambia, The Gambia
Actively Recruiting
Research Team
F
Fadzai E Munedzimwe, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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