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Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)

Study acronym: ORIENT
StatusRecruiting
PhasePhase 2/3
Started
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Record status
This record was last updated December 11, 2023 (before its estimated October 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Oct 1, 2023 to Oct 1, 2024
    • Eligibility criteria revised
    v3
  2. Phase: Phase 3 to Phase 2/3v2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 2904 to 2442
    • Start date changed from estimate of Nov 1, 2022 to Jan 13, 2023
    • Site details revised at 6 of 6 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens. This is a multicenter prospective, non-inferiority randomized controlled study. The purpose of our study is a) to evaluate the tolerability, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of the high-dose rifapentine, b) to evaluate whether the high-dose rifapentine-containing regimen has the potential to treat the rifampicin-sensitive pulmonary tuberculosis and shorten the course of treatment to 17 weeks. This study is of great significance for shortening the course of treatment, reducing the adverse reactions and economic burden of patients' treatment in rifampicin-sensitive tuberculosis patient.
Trial Details
NCT Number NCT05401071
Lead Sponsor Huashan Hospital
Conditions
(from sponsor)		 Tuberculosis, Pulmonary
Related terms Tuberculosis, Pulmonary
Enrollment 2,442 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov