Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Uganda
Makerere University Lung Institute
NOT_YET_RECRUITING
Kampala
Mulago National Referral Hospital
RECRUITING
Kampala
Contact Information
Primary
Ahmed Ddungu, MBCHB,MMED
ahddungu@yahoo.com
0782303377
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Treatments
Experimental: Intervention: Doxycycline
Oral doxycycline (100 mg) administered once daily for 12 weeks
Placebo_comparator: Control arm
Oral placebo (matching with doxycycline) will be administered once daily for 12 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Makerere University Lung Institute
Leads: Makerere University

This content was sourced from clinicaltrials.gov

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