Clinical Trial

Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline

Study acronym: TALF-TB
Recruiting Phase 2
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Summary
The goal of this clinical trial is to assess the efficacy(effectiveness) of doxycycline, a potent inhibitor of matrix metalloproteinase (lung collagenase) activity in prevention of Tuberculosis associated lung fibrosis and associated lung function decline among patients with drug sensitive advanced TB. The main question\[s\] it aims to answer are: * Does doxycycline have a significant anti-fibrosis role when given as adjuvant therapy to TB patients with advanced pulmonary TB in a double blind randomized placebo controlled trial? * How does long term respiratory function defer between patients who received adjuvant doxycycline aimed at prevention of TB associated lung fibrosis and those who received a placebo in a double blind randomized controlled trial? Participants will be subjected to the following: * Experimental arm: Doxycycline 100 mg once daily for 12 weeks administered concurrently with standard of care anti-TBs. * Comparator arm: Placebo once daily for 12 weeks administered concurrently with standard of care anti-TBs.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-24.
Status change: Not Yet Recruiting → Recruiting 2025-04-14
Trial Details
NCT Number NCT06477185
Lead Sponsor Makerere University
Collaborators: Makerere University Lung Institute
Conditions Tuberculosis, Pulmonary
Enrollment 200 participants
Start Date 2024-12-04
Primary Completion 2026-12-20 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-17