RecruitingPhase 3NCT05473520

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

Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis: A Phase III Randomized Control Trial (Doxy-TB)


Sponsor

National University Hospital, Singapore

Enrollment

150 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Tuberculosis (TB) is a global pandemic that despite successful treatment and bacterial eradication can cause chronic ill health, such as pulmonary impairment after tuberculosis (PIAT) and cardiovascular disease (CVD). A recent Phase 2b double-blind randomised-controlled clinical trial shows that adjunctive doxycycline therapy is safe, accelerates resolution of inflammation, suppresses tissue damaging enzyme activity and decreases pulmonary cavity volume (1). We aim to determine if adjunctive doxycycline can reduce PIAT and improve cardiovascular outcomes in a fully powered Phase III trial of 8 weeks of adjunctive doxycycline alongside standard pulmonary TB (PTB) treatment. The investigators hypothesize that doxycycline inhibits tissue destruction in patients with PTB and thereby leads to improved lung function after treatment. Specific aims 1. To assess improvement in lung function as measured by forced expiratory volume (FEV1) predicted in PTB patients given doxycycline versus placebo. 2. To investigate whether doxycycline will hasten the resolution of pulmonary cavities measured by CT thorax 3. To investigate whether doxycycline can suppress inflammatory markers including matrix metalloproteinases 4. To investigate whether doxycycline can accelerate time to sputum conversion 5. To evaluate the effect of doxycycline on cardiovascular outcomes such as the incidence of acute coronary syndrome (ACS) and pulmonary hypertension 6. To investigate whether doxycycline improves TB drug concentrations in sputum and plasma. 7. To assess the safety profile of doxycycline with concurrent standard anti-tuberculous treatment.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding doxycycline — an antibiotic commonly used for infections but also known to reduce inflammation and tissue damage — to standard tuberculosis (TB) treatment can better preserve lung function in patients with severe pulmonary TB. **You may be eligible if...** - You are 21 years or older - You have been newly diagnosed with pulmonary TB (TB in the lungs) confirmed by lab tests - Your chest X-ray shows one or more cavities (holes caused by TB damage) in the lungs - You are at the start of standard TB treatment (within 7 days or about to begin) **You may NOT be eligible if...** - You have HIV - You have had TB before - You have severe pre-existing lung disease (such as COPD, bronchiectasis, or pulmonary fibrosis) - You are pregnant or breastfeeding - You are allergic to tetracycline antibiotics (doxycycline is a tetracycline) - You have significant liver or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoxycycline

A dose of 100 mg twice daily of doxycycline based on the recommended dose for adults which is commonly used for bacterial infections such as rickettsial infection, lyme disease and pelvic inflammatory disease.

DRUGPlacebo

Placebo + standard anti-tuberculous treatment


Locations(6)

Hospital Queen Elizabeth I

Kota Kinabalu, Sabah, Malaysia

Klinik Kesihatan Luyang

Kota Kinabalu, Sabah, Malaysia

Klinik Kesihatan Menggatal

Kota Kinabalu, Sabah, Malaysia

Universiti Malaysia Sabah (UMS), Borneo Medical and Health Research Centre

Kota Kinabalu, Sabah, Malaysia

National University Hospital

Singapore, Singapore

TB Control Unit

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT05473520


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