Actively Recruiting
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in a Double Blind Randomized Controlled Trial
Led by Makerere University · Updated on 2025-04-17
200
Participants Needed
2
Research Sites
49 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
Researchers are evaluating whether doxycycline, a drug that inhibits enzymes causing lung damage, can prevent lung fibrosis and decline in lung function among patients with advanced drug-sensitive pulmonary tuberculosis (TB). The study aims to determine if doxycycline, given alongside standard TB treatment, has a significant anti-fibrosis effect compared to a placebo. This is a double-blind, randomized, placebo-controlled clinical trial focused on TB patients with advanced lung involvement. Participants will be randomly assigned to receive either 100 mg of doxycycline or a matching placebo once daily for 12 weeks, both given with standard anti-TB therapy. The study includes baseline and 12-month high-resolution CT scans to assess lung fibrosis. Lung function tests using spirometry will be performed at 6 and 12 months. Blood samples will be taken at baseline, 3 months, and 6 months to measure markers related to fibrosis and inflammation. During the study, participants will have scheduled visits for scans, lung function tests, and blood draws to monitor changes and compare outcomes between the doxycycline and placebo groups. Researchers will assess lung fibrosis scores, lung function trends, and levels of specific cytokines and enzymes over a 12-month period. The trial monitors participants' health and treatment adherence throughout the study period to evaluate the effectiveness of doxycycline in preventing TB-associated lung damage.
CONDITIONS
Brief 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 drug-sensitive pulmonary tuberculosis (positive sputum smear or GeneXpert with rifampicin sensitivity)
- Chest X-ray showing infiltrates in at least 2 lung zones indicating moderate or advanced pulmonary TB
- HIV negative
- Willing and able to comply with study visits, treatment plan, laboratory tests, and procedures
- Able to provide written informed consent
You will not qualify if you...
- Pregnancy
- Breastfeeding
- Baseline serum creatinine or liver enzymes more than 2 times the upper limit of normal
- Taking corticosteroids for 14 days or more or anti-TB drugs for more than 7 days prior to enrollment
- Currently enrolled in another clinical trial
- Diabetes or history of metformin use
- Malignancy or receiving anticancer medication
- Taking medications known to interact with doxycycline
- Known allergies to doxycycline or other tetracyclines
- Known autoimmune disease
- Any other factor that significantly increases risk of adverse events
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral doxycycline or matching placebo once daily for 12 weeks alongside standard anti-TB therapy.
Weekly visits for up to 12 weeks
Duration - Up to 12 months after enrollment
Participants undergo lung function assessments and repeat CT scans to evaluate lung fibrosis and respiratory function, with blood tests measuring profibrotic cytokines and matrix metalloproteinases.
Visits at 3, 6, and 12 months after enrollment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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