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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMakerere University

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Makerere University

Lead sponsor

Makerere University Lung Institute

Collaborator