Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis

Launched by NATIONAL UNIVERSITY HOSPITAL, SINGAPORE · Jul 21, 2022

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ClinConnect Summary

This clinical trial is studying the effects of a medication called doxycycline in patients with pulmonary tuberculosis (TB). While standard treatment can eliminate the TB bacteria, some people still experience ongoing lung problems afterward. The researchers want to see if adding doxycycline to the usual TB treatment can help improve lung function and reduce damage to lung tissue. They believe that doxycycline may help heal the lungs more quickly and effectively.

To participate in the trial, you must be at least 21 years old and either starting standard TB treatment or have been on treatment for less than a week. You should have a confirmed case of pulmonary TB with specific signs on your chest X-ray. However, if you have certain conditions like HIV, previous TB, or severe lung diseases, you won't be eligible. If you join, you'll receive either doxycycline or a placebo (a pill with no active medication) for eight weeks, along with your regular TB treatment. Throughout the trial, your lung function and overall health will be closely monitored to ensure safety and effectiveness.

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Eligibility criteria

• • The recruitment target would be 150 patients, with 75 in each arm
• Inclusion criteria: Patients should meet all criteria:
• • 1. Aged 21 years and above
• • 2. Patients receiving ≤ 7 days of TB treatment or about to start standard combination TB treatment
• • 3. Confirmed pulmonary TB with positive acid-fast bacilli smear and/or positive nucleic acid amplification test (NAAT) and/or TB culture results
• • 4. CXR demonstrating pulmonary involvement with cavity or cavities
• • 5. Able to provide informed consent
• Exclusion criteria:
• • 1. HIV co-infection
• • 2. Previous pulmonary TB
• • 3. Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, COPD and lung cancer
• • 4. Pregnant or breast feeding
• • 5. Allergies to tetracyclines
• • 6. Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity
• • 7. Autoimmune disease and/or on systemic immunosuppressants
• • 8. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of study drug, or planned use during the study period
• • 9. Enrolment in any other clinical trial involving a systemic drug or intervention involving the lung
• • 10. Evidence of severe depression, schizophrenia or mania
• • 11. ALT \> 3 times upper limit of normal
• • 12. Creatinine \> 2 times upper limit of normal
• • 13. Principal investigator assessment of lack of willingness to participate and comply with all requirements including follow-up of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome