Adjunctive N-Acetylcysteine and Lung Function in Pulmonary Tuberculosis.
Robert S Wallis, Issa Sabi, Julieth Lalashowi...
https://pubmed.ncbi.nlm.nih.gov/39189858Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06909799
A Confirmatory Trial of Adjunctive N-acetylcysteine to Prevent Post Tuberculosis Lung Disease (NAC-PTLD) - A TB SEQUEL II Substudy
Led by The Aurum Institute NPC · Updated on 2025-04-30
242
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating whether N-acetylcysteine (NAC) can help prevent post-tuberculosis lung disease (PTLD) in patients who have severe lung problems caused by pulmonary tuberculosis. The study also monitors the safety of NAC. It aims to find out if NAC improves lung function measured by FEV1% over 12 months in patients with pulmonary tuberculosis and risk factors for PTLD, and what medical issues or side effects occur during treatment. The trial compares NAC plus standard TB treatment to standard TB treatment alone. Participants will be randomly assigned to receive either NAC at a dose of 1800 mg twice daily along with standard TB treatment for the first 6 months, or standard TB treatment alone for 6 months. After the treatment period, participants will be followed for an additional 6 months. Standard TB treatment consists of fixed dose combination tablets. The trial is open-label and has parallel groups. During the 12-month study, participants will attend scheduled clinic visits for respiratory assessments, blood tests, and symptom monitoring. They will also complete quality-of-life questionnaires and provide sputum and blood samples at various times. Researchers will measure lung function, respiratory symptoms, quality of life, and laboratory markers including sputum culture and blood glutathione. Safety will be monitored through recording adverse events and liver function tests.
CONDITIONS
Brief Title
A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Persons aged 18 to 65 years
- Able and willing to provide signed written consent or witnessed oral consent if illiterate
- Body weight between 30 and 90 kg
- Confirmed pulmonary tuberculosis with rifampin-sensitive MTB by Xpert TB/RIF or Ultra and culture
- Chest X-ray showing moderate or far advanced pulmonary tuberculosis
- Lung function with FEV1 less than or equal to 65% of predicted adjusted for age, height, sex, and race
- If female and sexually active with child-bearing potential, agrees to use contraception during the study
- HIV negative, or if positive, CD4 count at least 100/mcL and currently on or willing to start ART during the study
You will not qualify if you...
- Any condition that may compromise well-being or interfere with study assessments, such as pneumothorax or significant pleural effusion
- Pregnancy or breastfeeding
- Critically ill with expected death during study or follow-up
- TB meningitis or other severe TB with high risk of poor outcome
- History of allergy or hypersensitivity to study drugs, including rifampin
- Participation in other investigational drug trials within 8 weeks prior or currently enrolled in such trials
- More than 5 days of treatment for current TB episode or any TB treatment in past 6 months
- Angina requiring treatment with nitrates
- Cardiac arrhythmia needing medication or significant ECG abnormalities
- Random blood glucose above 140 mg/dL or unstable diabetes requiring recent hospitalization
- Use of systemic corticosteroids within past 28 days or expected need during study
- Need for medications incompatible with rifampin such as HIV protease inhibitors
- Abnormal laboratory values including elevated creatinine, low hemoglobin or platelets, low potassium, elevated liver enzymes, high bilirubin, or positive hepatitis B surface antigen
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive either N-acetylcysteine (NAC) plus standard TB treatment or standard TB treatment alone for pulmonary tuberculosis.
Regular visits during treatment period (approximately monthly)
Follow-up
Duration - 6 months
Participants are followed for additional 6 months after treatment to monitor lung function, respiratory symptoms, quality of life, and safety outcomes.
Regular follow-up visits during this period (approximately monthly)
Trial Site Locations
Total: 1 location
1
MRC Unit The Gambia at LSHTM
Fajara, The Gambia, The Gambia
Actively Recruiting
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Research Team
F
Fadzai E Munedzimwe, MPH
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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