Taking people in GambiaNo phase

Tests N-acetylcysteine to prevent lung damage after tuberculosis

Tests N-acetylcysteine alongside standard treatment in adults with tuberculosis at risk of lasting lung damage.

Key facts

Who runs it: The Aurum Institute NPC
Where: Fajara, GambiaSee the site
Trial code: NCT06909799
Registry title: A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
Status: Recruiting
People taking part: 242 people, planned
Started: 28 Apr 2025
Expected to end: 31 Dec 2027
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: N-Acetyl Cysteine (NAC)
Standard TB treatment
Record updated: 30 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with newly diagnosed lung tuberculosis (TB) and reduced lung function. It tests whether N-acetylcysteine added to standard TB treatment prevents lasting lung damage.

Age: 18 to 65 years
Sex: All sexes can join.
Disease stage: Lung TB confirmed by test and culture, rifampin-sensitive, with a chest X-ray showing moderate or far advanced disease. FEV1 (a lung function measure) must be 65% or less of the predicted value.
Earlier treatment: No more than 5 days of treatment for the current TB episode, and no other TB treatment in the past 6 months. No steroid tablets or injections in the past 28 days.
Biomarker or test result: Xpert TB/RIF or Ultra test showing rifampin-sensitive TB, confirmed by culture. HIV negative, or HIV positive with CD4 count of 100/mcL or more and on or willing to start HIV treatment.

Main reasons for not taking part

Pregnancy or breast-feeding
TB meningitis or other severe forms of TB with high risk of a poor outcome
Critically ill, or a diagnosis likely to result in death during the trial
Heart problems needing treatment (angina needing nitrates, or rhythm problems needing medication)
Taking another investigational drug within 8 weeks, or abnormal blood results such as high blood sugar, liver or kidney values

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

Persons aged 18 to 65 years
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
Body weight (in light clothing without shoes) between 30 and 90 kg
Xpert TB/RIF OR Ultra showing RIF-S-MTB, with subsequent confirmation of MTB by culture
Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis 1
FEV1 ≤65% of predicted adjusted for age, height, sex, and race
If female, of child-bearing potential and sexually active, willing to use a contraceptive method for the duration of study participation
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

Who cannot take part

Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial
Angina pectoris requiring treatment with nitroglycerin or other nitrates
Patients requiring treatment with medications not compatible with rifampin, such as HIV protease inhibitors
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
TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome as judged by the investigator
History of allergy or hypersensitivity to any of the trial therapies or related substances, including known allergy or suspected hypersensitivity to rifampin
Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator
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
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
Subjects with any of the following abnormal laboratory values:; creatinine >2 mg/dL; haemoglobin <8 g/dL; platelets <100x109 cells/L; serum potassium <3.5; aspartate aminotransferase (AST) ≥2.0 x ULN; alkaline phosphatase (AP) >5.0 x ULN; total bilirubin >1.5 mg/dL; positive HBsAg
Pregnancy or breast-feeding
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
No more than 5 days treatment for the current TB episode, and no other TB treatment in the preceding 6 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

Where in Gambia

MRC Unit The Gambia at LSHTMFajara, GambiaContact: Bintou Njai, MBBSTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

N-Acetylcysteine (NAC) 1800mg orally twice a day plus TB treatment during months 1-6.Treatment being tested
N-Acetylcysteine (NAC) dosing will be 1800mg orally twice a day during months 1-6 plus standard TB treatment. This will be followed by 6 months follow up.
Treatment: N-Acetyl Cysteine (NAC) and Standard TB treatment
Standard TB treatment during months 1-6Existing treatment, for comparison
Standard TB treatment for 6 months followed by 6 months of observation. TB treatment will be provided as fixed dose combination tablets.
Treatment: Standard TB treatment