Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline

Launched by MAKERERE UNIVERSITY · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called doxycycline in preventing lung damage and breathing problems caused by tuberculosis (TB) in patients with advanced disease. The trial aims to find out if doxycycline can help reduce fibrosis, which is the thickening and scarring of lung tissue, when given alongside standard TB treatment. Participants will be divided into two groups: one will receive doxycycline daily for 12 weeks, while the other will receive a placebo (a non-active pill) for the same duration, both in addition to their regular TB medications.

To be eligible for this trial, participants need to be between 18 and 65 years old, have a confirmed case of TB with significant lung involvement, and be HIV negative. They should also be willing to attend regular check-ups and follow the treatment plan. Those who are pregnant, breastfeeding, have certain health conditions, or are on specific medications will not be able to join. Participants can expect regular visits for assessments throughout the trial, helping researchers understand how doxycycline impacts lung health over time. Overall, the trial aims to gather important information that could improve the care of TB patients in the future.

Gender

ALL

Eligibility 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