A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease

ConditionTuberculosis (TB)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorThe Aurum Institute NPC

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

N-Acetyl Cysteine (NAC)
Standard TB treatment

Treatment groups

242 Participants

are divided into 2 treatment groups

Sponsors and collaborators

The Aurum Institute NPC

Lead sponsor

Ludwig-Maximilians - University of Munich

Collaborator

Research Center Borstel

Collaborator

Source ClinicalTrials.gov