RecruitingPhase 2

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

Uganda200 participantsStarted 2024-12-04

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean High resolution CT (HRCT) fibrosis scores

Timeframe: 12 months

Efficacy of doxycycline as an anti-TB associated fibrosis agent

Timeframe: 12 months

Trial details

NCT IDNCT06477185

SponsorMakerere University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-20

Contact for this trial

Ahmed Ddungu, MBCHB,MMED

0782303377 ahddungu@yahoo.com

View on ClinicalTrials.gov More Tuberculosis, Pulmonary trials