Using Doxycycline to Prevent Lung Fibrosis in Tuberculosis Patients
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Makerere University Academic / other |
| Locations | 2 sites (Kampala, Kampala and 1 other locations) |
| Trial ID | NCT06477185 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with advanced drug-sensitive pulmonary tuberculosis and no significant comorbidities.
Not a fit: Patients who are pregnant, breastfeeding, or have conditions such as diabetes or malignancies may not benefit from this study.
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 performed: While the use of doxycycline in this context is novel, previous studies have explored anti-fibrotic therapies in lung diseases, indicating potential for success.
Eligibility criteria
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 this trial is running
Kampala, Kampala and 1 other locations
- Makerere University Lung Institute — Kampala, Kampala, Uganda (Not_yet_recruiting)
- Mulago National Referral Hospital — Kampala, Uganda (Recruiting)
Study contacts
- Study coordinator: Ahmed Ddungu, MBCHB,MMED
- Email: ahddungu@yahoo.com
- Phone: 0782303377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.