Using doxycycline to improve lung function in tuberculosis patients
Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis: A Phase III Randomized Control Trial (Doxy-TB)
This study is testing if adding doxycycline to the standard treatment for tuberculosis can help improve lung function and reduce damage in patients with lung infections.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 6 sites (Kota Kinabalu, Sabah and 5 other locations) |
| Trial ID | NCT05473520 on ClinicalTrials.gov |
What this trial studies
This Phase 3 double-blind randomized-controlled trial investigates the effectiveness of adjunctive doxycycline therapy in improving lung function and reducing tissue damage in patients with pulmonary tuberculosis (PTB). A total of 150 participants will receive either doxycycline or a placebo alongside standard TB treatment for 8 weeks, followed by a 4-month follow-up. The study will assess lung function through forced expiratory volume tests and analyze sputum and blood samples to evaluate the impact of doxycycline on inflammation and tissue destruction. The goal is to determine if doxycycline can decrease pulmonary impairment after tuberculosis treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and above who are starting standard TB treatment and have confirmed pulmonary TB with cavities.
Not a fit: Patients with HIV co-infection, previous pulmonary TB, or severe pre-existing lung diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients recovering from tuberculosis.
How similar studies have performed: Previous studies have shown promising results with doxycycline in reducing inflammation and tissue damage in TB patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kota Kinabalu, Sabah and 5 other locations
- Hospital Queen Elizabeth I — Kota Kinabalu, Sabah, Malaysia (Not_yet_recruiting)
- Klinik Kesihatan Luyang — Kota Kinabalu, Sabah, Malaysia (Active_not_recruiting)
- Klinik Kesihatan Menggatal — Kota Kinabalu, Sabah, Malaysia (Recruiting)
- Universiti Malaysia Sabah (UMS), Borneo Medical and Health Research Centre — Kota Kinabalu, Sabah, Malaysia (Active_not_recruiting)
- National University Hospital — Singapore, Singapore (Recruiting)
- TB Control Unit — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Catherine Ong, MRCP PhD — National University Hospital, Singapore
- Study coordinator: Srishti CHHABRA, MBBS BSc MRCP
- Email: srishti.chhabra@mohh.com.sg
- Phone: +65 6908 2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.