Status:
RECRUITING
A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
Lead Sponsor:
The Aurum Institute NPC
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Research Center Borstel
Conditions:
Tuberculosis (TB)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
Study Summary: This prospective, randomized, controlled, parallel-arm, open-label clinical trial evaluates the efficacy of N-acetylcysteine (NAC) as an adjunctive therapy for persons with pulmonary tu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
- 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.
- Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.
- No more than 5 days treatment for the current TB episode, and no other TB treatment in the preceding 6 months
- Angina pectoris requiring treatment with nitroglycerin or other nitrates
- Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator
- 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.
- 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.
- Patients requiring treatment with medications not compatible with rifampin, such as HIV protease inhibitors
- 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
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06909799
Start Date
April 28 2025
End Date
December 31 2027
Last Update
April 30 2025
Active Locations (1)
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1
MRC Unit The Gambia at LSHTM
Fajara, The Gambia, The Gambia