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Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

NCT06649721•Huashan Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are willing to sign informed consent of this trial, those without capacity for civil conduct need their legal guardian to sign
•Participants (and their legal guardian if applicable) are willing to cooperate to complete all trial procedures
•Male or female, 12 years or older, weight ≥ 30kg
•Confirmed pulmonary tuberculosis with resistance to rifampin by phenotypic or genotypic susceptibility testing within 3 months, and must be re-confirmed by sputum culture sampled at trial inclusion
•Women with childbearing potential should not be pregnant, confirmed by a volunteered negative pregnancy test, and are willing to use effective contraceptive method from giving consent to 3 months after study treatment
•Men with childbearing potential must be willing to use condom or other effective contraceptive methods to avoid their sex partners from being pregnant
•Women in breastfeeding period must be willing to discontinue breastfeeding from giving consent to 3 months after study treatment
•Participants are willing to take HIV test, and willing to take appropriate antiretroviral therapy if positive

Exclusion Criteria

•Previously use of Bedaquiline or Delamanid for at least 28 days
•Concomitant hematogenous disseminated tuberculosis, or severe pulmonary tuberculosis in investigator's opinion (including tuberculosis of the digestive system, osteoarticular tuberculosis or tuberculous meningitis)
•Currently using any drug that has been prohibited in the protocol
•History of allergic action to any of the study drugs
•Currently participating in any other clinical trials
•Cardiovascular risk at screening: (1) QTcF more than 480 milliseconds (ms); (2) History of clinically significant arrythmia, and at investigator's opinion, participation in this study will increase the risk; (3) Decompensated heart failure; (4) Grade 3 high blood pressure and the goals of treatment have not been reached; (5) Abnormal thyroid function; (6) Abnormal serum Ca, Mg or K level; (7) Other conditions with cardiovascular risks in investigator's opinion.
•History of optic neuropathy or peripheral neuropathy, and the investigator considers that the condition may progress or deteriorate by participating in the study, or inappropriate to participate
•Hepatic disorders at screening: (1) Active viral hepatitis: HBsAg positive or HBV DNA \>1000 CPs/mL, with elevated AST or ALT or HCV RNA positive; (2) Decompensated cirrhosis
•Renal disorders at screening: (1) Unstable or rapidly progressive renal disease; (2) Moderate / severe renal disfunction or end-stage renal disease (eGFR\< 60 mL/min/1.73 m2); (3) Serum creatinine ≥133 μmol/L(1.5 mg/mL) in men, or ≥124 μmol/L (1.4 mg/mL) in women
•Other abnormal laboratory test: (1) Hemoglobin \< 8.0g/dL; (2) Platelet \<75,000/mm3; (3) Absolute neutrophil count \<1000/mm3; (4) Aspartate transaminase (AST) or alanine aminotransferase (ALT) \>3×upper limit of normal (ULN); (5) Total bilirubin (TBil) \>2×ULN, or \>1.5×ULN together with abnormal AST or ALT; (6) Albumin \<30g/L
+1 more criteria

Locations (34)

Anhui Chest Hospital

Hefei, Anhui, China

The 8th Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The Fourth People's Hospital of Nanning

Nanning, Guangxi, China

Liupanshui Third People's Hospital

Liupanshui, Guizhou, China

Hebei Chest Hospital

Shijiazhuang, Hebei, China

The Fifth Hospital of Shijiazhuang

Shijiazhuang, Hebei, China

Infectious Disease Hospital of Heilongjiang Province

Harbin, Heilongjiang, China

Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)

Jiamusi, Heilongjiang, China

Harbin Chest Hospital

Harbin, Helongjiang, China

Key Dates

Start Date

November 27, 2024

Primary Completion Date

February 28, 2027

Completion Date

June 30, 2027

Last Updated

September 2, 2025

Enrollment

120

ESTIMATED participants

Conditions

Drug-resistant TuberculosisPulmonary TuberculosisRifampin-resistant Tuberculosis

Interventions

bedaquiline

DRUG

delamanid

DRUG

linezolid

DRUG

Levofloxacin

DRUG

Clofazimine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Novel Triple-dose Tuberculosis Retreatment Regimen

A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis

Rehabilitation of People With Post-tuberculosis Lung Disease

Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

A Study on the Short - Course Treatment Regimen Containing Pretomanid for Diabetes Mellitus Complicated With Rifampicin - Resistant/Multidrug - Resistant Pulmonary Tuberculosis