Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Tuberculosis, Pulmonary
In brief
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.
Key facts
- Study ID
- NCT06477185
- Run by
- Makerere University
- People needed
- 200
- Starts
- 2024-12-04
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-04-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Mulago National Referral Hospital — Kampala, Uganda (enrolling)
- Makerere University Lung Institute — Kampala, Kampala, Uganda
Full record on ClinicalTrials.gov
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