Using Doxycycline to Prevent Lung Fibrosis in Tuberculosis Patients
Official title: Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial
Run by Makerere University · NCT06477185 · Data updated 2026-11-12
This study is testing if doxycycline can help prevent lung damage in people with advanced tuberculosis while they receive standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Makerere University Academic / other |
| Locations | 2 sites (Kampala, Kampala and 1 other locations) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | December 20, 2026 |
| Study ends | December 2027 |
| Registry record updated | April 17, 2025 |
| Trial ID | NCT06477185 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with advanced drug-sensitive pulmonary tuberculosis and no significant comorbidities.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have conditions such as diabetes or malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of doxycycline as an adjuvant therapy in preventing lung fibrosis and respiratory impairment in patients with advanced drug-sensitive tuberculosis (TB). Participants will be randomly assigned to receive either doxycycline or a placebo for 12 weeks alongside standard TB treatment. The study will assess lung function and fibrosis through high-resolution CT scans and spirometry at baseline, 6 months, and 12 months. The trial will also measure levels of profibrotic cytokines and matrix metalloproteinases to understand the drug's impact on lung health.
Why it matters
Potential benefit: If successful, this trial could provide a new therapeutic option to prevent lung damage in TB patients, improving their long-term respiratory health.
How similar studies have gone: While the use of doxycycline in this context is novel, previous studies have explored anti-fibrotic therapies in lung diseases, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Mulago National Referral Hospital
Kampala, Uganda Recruiting -
Makerere University Lung Institute
Kampala, Kampala, Uganda Not yet recruiting
Study contacts
- Study coordinator: Ahmed Ddungu, MBCHB,MMED
- Email: ahddungu@yahoo.com
- Phone: 0782303377
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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FAP PET/CT in adults with pulmonary TB
This early-phase study tests whether a FAP PET/CT scan can map lung fibrosis in adults with pulmonary TB before starting treatment and after cure.
-
Sorfequiline-based regimens for adults with newly diagnosed drug-sensitive pulmonary TB
This study tests two sorfequiline-containing regimens, each with pretomanid and linezolid, to see if they are safe and effective in adults with newly diagnosed drug-sensitive pulmonary TB.
-
Digital health tool to help more people start TB preventive therapy
A digital health approach is being tested to see if it helps household and close contacts of people with drug-sensitive pulmonary TB start TB preventive therapy better.
-
Ear acupuncture to reduce nausea and vomiting from tuberculosis medicines
This trial will test whether press-needle ear acupuncture can reduce nausea and vomiting in people taking medicines for pulmonary tuberculosis.
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18F-FAPI-74 PET imaging for lung fibrosis in tuberculosis
This project tries to see if 18F-FAPI-74 PET scans can detect lung fibrosis in adults with active or recently treated tuberculosis.
-
Blood TB DNA test to track treatment progress
This project will test whether levels of TB-derived cell-free DNA in the blood can track treatment response in adults newly diagnosed with tuberculosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.