NCT06477185RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Aug 2023
- Start date
- 4 Dec 2024
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- Makerere University
- Diseases
- Tuberculosis
- NCT number
- NCT06477185
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 4 Dec 2024 to the primary completion date, 20 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking corticosteroids for ≥14 days or anti-TBs \>7days
- Situation where a participant is taking a drug/medication known to interact with the trial drug.
Other illness
- 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
- Known allergies to doxycycline or other tetracyclines
- Known autoimmune disease
Lab values
- Baseline serum creatinine or liver enzymes \>2 times above upper limit of normal
Other
- Pregnancy
- Breastfeeding
- Prospects already enrolled in another clinical trial
- Any factor felt to significantly increase risk of adverse event
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mulago National Referral Hospital Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| Makerere University Lung Institute Coordinator of this site? Confirm its status | Kampala | Uganda | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.