Using doxycycline to improve lung function in tuberculosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 ≤ 14 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 it's running

• Klinik Kesihatan Menggatal
  Kota Kinabalu, Sabah, Malaysia Recruiting
• National University Hospital
  Singapore, Singapore, Singapore Recruiting
• TB Control Unit
  Singapore, Singapore Recruiting
• Hospital Queen Elizabeth I
  Kota Kinabalu, Sabah, Malaysia Not yet recruiting
• Klinik Kesihatan Luyang
  Kota Kinabalu, Sabah, Malaysia Active not recruiting
• Universiti Malaysia Sabah (UMS), Borneo Medical and Health Research Centre
  Kota Kinabalu, Sabah, Malaysia Active not 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.