Tests doxycycline to prevent lung scarring in tuberculosis patients
Tests doxycycline alongside standard TB medicines in adults with advanced drug-sensitive tuberculosis.
Plain-language title generated from the registry record
Registry title: Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline
Key facts
- Where
- Kampala, UgandaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06477185, who can take part
Where in Uganda
- Makerere University Lung InstituteKampala, UgandaNot yet recruiting
- Mulago National Referral HospitalKampala, UgandaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Makerere University
- Trial code
- NCT06477185
- Record updated
- 17 April 2025
- Original description
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:Read full original descriptionShow less
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial
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.
Inclusion: 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: 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; 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; Baseline serum creatinine or liver enzymes >2 times above upper limit of normal; Pregnancy; Breastfeeding; Prospects already enrolled in another clinical trial; Any factor felt to significantly increase risk of adverse event.