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โ† Trials
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Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline

RecruitingPhase 2Ages 18 Years - 65 YearsAllMakerere University
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In plain words

What the trial is, and whether it could suit you

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 concurr

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ30% 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 โ‰ฅ14 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
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What it tests

  • Doxycycline
  • Placebo
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Where

2 sites
Makerere University Lung Institute
Kampala, Uganda
Mulago National Referral Hospital
Kampala, Uganda
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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