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

NCT06909799 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-04-30

No results posted yet for this study

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 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

  • Tuberculosis (TB)

Interventions

DRUG

N-Acetyl Cysteine (NAC)

NAC will be provided as 600 mg capsules from NOW Healthgroup. Standard TB treatment will be provided as fixed dose combination tablets.

DRUG

Standard TB treatment

Standard TB treatment will be provided as fixed dose combination tablets.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Research Center Borstel

    collaborator OTHER

  • The Aurum Institute NPC

    lead OTHER

Principal Investigators

  • Robert Wallis - Professor · Aurum Institute

  • Andrea Rachow, MD · LMU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • The Gambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909799 on ClinicalTrials.gov