Actively Recruiting
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline
Led by Makerere University · Updated on 2025-04-17
200
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Makerere University
Lead Sponsor
M
Makerere University Lung Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 - 65 years
- Confirmed index pulmonary tuberculosis episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility)
- Baseline chest X-ray showing infiltrates in at least 2 lung zones (≥30% lung involvement) consistent with moderate/advanced pulmonary TB
- HIV uninfected
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and study procedures
- Able to give written informed consent
You will not qualify if you...
- Pregnancy
- Breastfeeding
- Baseline serum creatinine or liver enzymes greater than 2 times the upper limit of normal
- Taking corticosteroids for 14 or more days or anti-TB drugs for more than 7 days
- Already enrolled in another clinical trial
- Diabetes or history of metformin use
- Presence of malignancy or receiving anticancer medication
- Using drugs known to interact with doxycycline
- Known allergies to doxycycline or other tetracyclines
- Known autoimmune disease
- Any factor that significantly increases risk of adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Makerere University Lung Institute
Kampala, Kampala, Uganda, 00256
Not Yet Recruiting
2
Mulago National Referral Hospital
Kampala, Uganda, 00256
Actively Recruiting
Research Team
A
Ahmed Ddungu, MBCHB,MMED
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here