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New treatment option for Tuberculosis
Official title Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis
ClinicalTrials.gov ID: NCT05473520
What this study is testing
What is Doxycycline?
Doxycycline is an investigational medicine, given as an once-daily, being studied as a potential treatment for tuberculosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- The recruitment target would be 150 patients, with 75 in each arm Patients should meet all criteria:
- Aged 21 years and above
- Patients receiving ≤ 14 days of TB treatment or about to start standard combination TB treatment
- Confirmed pulmonary TB with positive acid-fast bacilli smear and/or positive nucleic acid amplification test (NAAT) and/or TB culture results
- CXR demonstrating pulmonary involvement with cavity or cavities
You likely can't join if
- HIV co-infection
- Previous pulmonary TB
- Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, COPD and lung cancer
- Pregnant or breast feeding
- Allergies to tetracyclines
- Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity
See the full eligibility criteria
- The recruitment target would be 150 patients, with 75 in each arm Patients should meet all criteria:
- Aged 21 years and above
- Patients receiving ≤ 14 days of TB treatment or about to start standard combination TB treatment
- Confirmed pulmonary TB with positive acid-fast bacilli smear and/or positive nucleic acid amplification test (NAAT) and/or TB culture results
- CXR demonstrating pulmonary involvement with cavity or cavities
- Able to provide informed consent
- HIV co-infection
- Previous pulmonary TB
- Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, COPD and lung cancer
- Pregnant or breast feeding
- Allergies to tetracyclines
- Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity
- Autoimmune disease and/or on systemic immunosuppressants
- 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
- Enrolment in any other clinical trial involving a systemic drug or intervention involving the lung
- Evidence of severe depression, schizophrenia or mania
- ALT \> 3 times upper limit of normal
- Creatinine \> 2 times upper limit of normal
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Kota Kinabalu, Sabah, Malaysia
- Singapore, Singapore, Singapore
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kota Kinabalu, Sabah, Malaysia; Singapore, Singapore, Singapore; Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.