NCT05401071: ORIENT

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

Recruiting now Phase 2, PHASE3 Last updated 11 December 2023

What this trial tests

Phase 2, PHASE3 trial testing Short Regimen with Rifapentine 10mg/kg in Tuberculosis, Pulmonary in 2,442 participants. Currently enrolling.

Timeline

13 January 2023

Primary endpoint
1 October 2024

1 November 2027

Quick facts

Lead sponsor	Huashan Hospital
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2,442
Start date	13 January 2023
Primary completion	1 October 2024
Estimated completion	1 November 2027
Sites	6 locations across China

Drugs / interventions tested

• Short Regimen with Rifapentine 10mg/kg
• Standardized Regimen
• Short Regimen with Rifapentine 15mg/kg
• Short Regimen with Rifapentine 20mg/kg

Conditions studied

• Tuberculosis, Pulmonary — all drugs for Tuberculosis, Pulmonary →

Sponsor

Huashan Hospital

Who can join

Adults 18 to 60, any sex, with Tuberculosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Optimizing (O) rifapentine-based (RI) regimen and shortening (EN) the treatment of drug-susceptible tuberculosis (T) (ORIENT) using an adaptive seamless design: study protocol of a multicenter randomized controlled trial.
   Feng Z, Miao Y, Peng Y, Sun F, et al · · 2023 · cited 4× · PMID 37158831 · DOI 10.1186/s12879-023-08264-2
2. Rifapentine dosing for drug-susceptible tuberculosis: stage 1 of a seamless phase 2/3 randomized clinical trial.
   Li Y, Song L, Feng Z, Zhang X, et al · · 2026 · PMID 41974353 · DOI 10.1016/j.cmi.2026.04.004