TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Results first posted: Jul 7, 2026v5 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: estimated 230 to confirmed 158
    • Interventions: Rifapentine + isoniazid once weekly for 3 months (Drug) to Isoniazid (Drug), Rifapentine (Drug)
    • Secondary endpoints: 5 to 1
    • Site details revised at 1 of 24 sites
    • Study arms: 0 to 2
  2. Primary endpoint revisedv4 Show 4 more changesShow less
    • Trial status: Recruiting to Completed
    • Primary and study completion dates: Aug 2008
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 24 of 24 sites
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoint revised
    • Study sites: 23 to 24
    • Secondary endpoints revised (5)
    v2
  5. Study First Submitted
  • 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.
Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for the treatment of latent tuberculosis infection, has been amended to include children ages 2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and isoniazid. An adult control is enrolled for each child enrolled.
Trial Details
NCT Number NCT00164450
Lead Sponsor Centers for Disease Control and Prevention
Collaborators: US Department of Veterans Affairs
Conditions
(from sponsor)		 Tuberculosis
Related terms Tuberculosis
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov