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Adjunctive Doxycycline for Central Nervous System Tuberculosis

Study acronym: DIRECT
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Study sites: 5 to 6v4
  2. Minor Start date changed from estimate of Jul 2025 to Aug 21, 2025
    • Site contacts updated at 1 of 5 sites
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date: Jul 2024 to Jul 2025
    • Primary endpoint revised
    • Study sites: 1 to 5
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints revised (7)
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Although tuberculosis is now considered a treatable disease, central nervous system tuberculosis (CNS-TB) when managed with the current standard-of-care (SOC), still has mortality rates ranging from 30-50% even in tertiary hospital centers. At present, the SOC for the management of CNS-TB is anti-tuberculous therapy with adjunctive corticosteroids. In CNS-TB, the activity of pathogenic host matrix metalloproteinases (MMPs) is unopposed to tissue inhibitors of metalloproteinases (TIMPs), resulting in a matrix-degrading phenotype which may drive worse outcomes in CNS-TB. In a prior established CNS-TB murine model, the investigators have demonstrated that adjunctive MMP inhibition using doxycycline, a widely available and cheap drug, in addition to standard TB treatment, compared with standard TB treatment alone, improved murine survival (Manuscript in preparation). The investigators previously showed that in humans with pulmonary TB, doxycycline with anti-TB treatment is safe, accelerates the resolution of inflammation, and suppresses systemic and respiratory MMPs. Hence, the investigators are now ideally positioned to determine if adjunctive doxycycline in patients with CNS-TB can improve clinical outcomes. The investigators will perform a Phase 2 double-blind randomized-controlled trial (RCT) of adjunctive doxycycline versus placebo with standard TB treatment and steroids for 8 weeks, with the primary outcome of 8-week mortality or severe neurological deficits.
Trial Details
NCT Number NCT06446245
Lead Sponsor National University Hospital, Singapore
Collaborators: National Medical Research Council (NMRC), Singapore
Conditions
(from sponsor)
Tuberculosis, Meningeal, Tuberculosis; Meningitis (Etiology), Tuberculosis, Central Nervous System, Tuberculosis; Meningoencephalitis (Etiology)
Related terms Meningitis, Meningoencephalitis, Tuberculosis, Tuberculosis, Central Nervous System, Tuberculosis, Meningeal
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov