Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial
Makerere University
200 participants
Dec 4, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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
- Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Able to give written informed consent.
Exclusion Criteria11
- Pregnancy
- Breastfeeding
- Baseline serum creatinine or liver enzymes >2 times above upper limit of normal
- Taking corticosteroids for ≥14 days or anti-TBs >7days
- Prospects already enrolled in another clinical trial
- Diabetic patients (most diabetics are on metformin or have history of metformin use. Metformin is postulated to have an anti-fibrosis role)
- Patients with malignancy or on anticancer medication
- Situation where a participant is taking a drug/medication known to interact with the trial drug.
- Known allergies to doxycycline or other tetracyclines
- Known autoimmune disease
- Any factor felt to significantly increase risk of adverse event
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Interventions
Doxycycline is a bacteriostatic tetracycline antibiotic with ability to immunomodulate matrix metalloproteinases, enzymes well known to cause lung damage via breakdown lung extracellular matrix.
This will be a chemically inert substance, designed to match oral doxycycline capsules but with no chemically active ingredients.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06477185