Old antibiotic, new hope: doxycycline may shield TB patients from lasting lung harm
NCT ID NCT05473520
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether adding doxycycline to standard tuberculosis treatment can reduce permanent lung damage and lower the risk of heart problems. Researchers will give 150 adults either doxycycline or a placebo for 8 weeks alongside their TB medication. The main goal is to see if lung function improves at 6 months, with follow-up for up to 2 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxycycline
- What this could lead to
- If it works, this could point toward a way to prevent permanent lung damage and heart problems after tuberculosis treatment.
- What could go wrong
- This is a mid-stage trial with only 150 participants, so results may not apply to everyone. Doxycycline can cause side effects like sun sensitivity and stomach upset.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2023
- Expected to finish
-
Jan 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute coronary syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hospital Queen Elizabeth I
NOT_YET_RECRUITINGKota Kinabalu, Sabah, Malaysia
-
Klinik Kesihatan Luyang
ACTIVE_NOT_RECRUITINGKota Kinabalu, Sabah, Malaysia
-
Klinik Kesihatan Menggatal
RECRUITINGKota Kinabalu, Sabah, Malaysia
-
National University Hospital
RECRUITINGSingapore, Singapore, 119228, Singapore
-
TB Control Unit
RECRUITINGSingapore, Singapore
-
Universiti Malaysia Sabah (UMS), Borneo Medical and Health Research Centre
ACTIVE_NOT_RECRUITINGKota Kinabalu, Sabah, Malaysia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tailoring cardiac rehab to each heart: can personalized training speed recovery?
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Can a 20-Minute playlist calm a heart attack Patient's nerves?
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Fish oil meets TB drugs: can Omega-3 help clear infection faster?