About this trial
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.
Eligibility criteria
Qualifiers
Age of 18 - 65 years
Index PTB episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility)
Baseline CXR showing infiltrates in at least 2 lung zones (≥30% lung involvement) meeting criteria for moderate/advanced PTB
HIV uninfected
Disqualifiers
Pregnancy
Breastfeeding
Baseline serum creatinine or liver enzymes >2 times above upper limit of normal
Taking corticosteroids for ≥14 days or anti-TBs >7days
Trial design
Treatments tested in this trial
- Doxycycline
- Placebo
Treatment groups
Sponsors and collaborators
Makerere University
Lead sponsor
Makerere University Lung Institute
Collaborator