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

Study acronym: Doxy-TB
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Minor Eligibility criteria revised
    • Site details revised at 1 of 6 sites
    v11
  2. Notable Primary completion date: Apr 23, 2026 to Jan 31, 2030v10 Show 4 more changesShow less
    • Study sites: 4 to 6
    • Study completion date: Jan 27, 2027 to Jan 31, 2030
    • Secondary endpoints: 12 to 15
    • Study description expanded, about 36 words
  3. Minor Study sites: 1 to 4
    • Collaborators: 3 to 6
    v9
  4. Minor Secondary endpoints: details revised at 1 of 12 entriesv8
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 24, 2023 to May 24, 2023
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Secondary endpoints: details revised at 1 of 12 entries
    • Study description expanded, about 4 words
    v6
  2. Notable Primary completion date: Apr 23, 2024 to Apr 23, 2026
    • Start date: Apr 24, 2023 to Oct 24, 2023
    • Study completion date: Dec 27, 2024 to Jan 27, 2027
    v5
  3. Notable Start date: Oct 3, 2022 to Apr 24, 2023
    • Primary completion date: Oct 3, 2024 to Apr 23, 2024
    v4
  4. Minor Secondary endpoints revised (12)v3
  5. Minor Secondary endpoints: 1 to 12v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05473520
Lead Sponsor National University Hospital, Singapore
Collaborators: Tan Tock Seng Hospital, Hospital Queen Elizabeth, Malaysia, National University of Singapore, University Malaysia Sabah, Menggatal Health Clinic, Sabah, Malaysia, Luyang Health Clinic, Sabah, Malaysia
Conditions
(from sponsor)
Tuberculosis, Acute Coronary Syndrome, Pulmonary Hypertension (Diagnosis)
Related terms Acute Coronary Syndrome, Disease, Hypertension, Pulmonary, Tuberculosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov