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Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

NCT06649721 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-02

No results posted yet for this study

Summary

This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC regimen, to treat rifampin-resistant pulmonary tuberculosis (RR-TB) in Chinese teenagers and adults (aged 12 years or above). The main questions it aims to answer are:

* Is BDLLfxC regimen effective to treat RR-TB in Chinese participants?
* Is BDLLfxC regimen safe in Chinese RR-TB participants? Participants will take BDLLfxC regimen to treat their RR-TB. There will be no additional hospital visits, laboratory tests or radiological examinations other than routine clinical practice.

Conditions

  • Drug-resistant Tuberculosis
  • Pulmonary Tuberculosis
  • Rifampin-resistant Tuberculosis

Interventions

DRUG

bedaquiline

400 milligrams (mg) daily for 2 weeks(w), then 200mg three times a week for 22 weeks (w)

DRUG

delamanid

* for participants weighing up to 33.9 kilograms (kg): 50mg two times a day for 24w * for participants weighing 34kg or above: 100mg two times a day for 8w, then 200mg daily for 16w

DRUG

linezolid

* for participants weighing up to 33.9kg: 450mg daily; * for participants weighing 34kg or above: 600mg daily; for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w

DRUG

Levofloxacin

Only for participants with confirmed fluoroquinolone-susceptible TB or unknown fluoroquinolone susceptibility: * for participants weighing up to 33.9kg: 500mg daily * for participants weighing 34kg to 49.9kg: 750 daily * for participants weighing 50kg or above: 1000mg daily for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w

DRUG

Clofazimine

Only for participants with confirmed fluoroquinolone-resistant TB or unknown fluoroquinolone susceptibility: 100mg daily, for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w

Sponsors & Collaborators

  • Beijing Chest Hospital

    collaborator OTHER

  • Huashan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-27
Primary Completion
2027-02-28
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649721 on ClinicalTrials.gov