Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477185
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-08-10
Brief Title:
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment and Prevention Using Doxycycline
Sponsor:
Makerere University
Organization:
Makerere University
Study Overview
Official Title:
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TALF-TB
Brief Summary:
The goal of this clinical trial is to assess the efficacyeffectiveness 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 questions 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
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
Detailed Description:
This will be a double-blind randomized block stratified clinical trial Participants will be enrolled if they have advanced drug sensitive TB evidenced by infiltrateslesions in at least 2 zones on a chest X-ray among other inclusion criteria
Participants will receive 100mg of doxycycline or matching placebo once a day for 12 weeks in addition to standard anti TB therapy
Participants will undergo baseline high resolution CT scans to evaluate lung parenchyma involvement and repeat CT scans at 12 months to score TB associated fibrosis
Lung function assessment with spirometry will be done at 6 and 12 months after enrolment to assess trends of lung function in the control and intervention study arms
Profibrotic cytokines TGFbeta and Matrix metalloproteinases 1 3 89 will be measured at baseline 3 and 6 months after enrolment
Participants will receive 100mg of doxycycline or matching placebo once a day for 12 weeks in addition to standard anti TB therapy
Participants will undergo baseline high resolution CT scans to evaluate lung parenchyma involvement and repeat CT scans at 12 months to score TB associated fibrosis
Lung function assessment with spirometry will be done at 6 and 12 months after enrolment to assess trends of lung function in the control and intervention study arms
Profibrotic cytokines TGFbeta and Matrix metalloproteinases 1 3 89 will be measured at baseline 3 and 6 months after enrolment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None