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Shorter all-oral treatment for drug-resistant tuberculosis in China

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

Phase 3 Interventional Huashan Hospital · NCT06649721

This study is testing a new 6-month all-pill treatment for drug-resistant tuberculosis to see if it works well and is safe for teenagers and adults in China.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment120 (estimated)
Ages12 Years and up
SexAll
SponsorHuashan Hospital Academic / other
Locations34 sites (Hefei, Anhui and 33 other locations)
Trial IDNCT06649721 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a 6-month all-oral treatment regimen for rifampin-resistant pulmonary tuberculosis in Chinese teenagers and adults. The regimen includes a combination of Bedaquiline, Delamanid, Linezolid, Levofloxacin, and Clofazimine. Participants will receive the treatment without additional hospital visits or tests beyond routine clinical practice. The study aims to determine if this new regimen is effective and safe for treating drug-resistant tuberculosis in this population.

Who should consider this trial

Good fit: Ideal candidates are Chinese teenagers and adults aged 12 years or older with confirmed rifampin-resistant pulmonary tuberculosis.

Not a fit: Patients who do not have rifampin-resistant tuberculosis or are under 12 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and convenient option for patients suffering from drug-resistant tuberculosis.

How similar studies have performed: Other studies have shown promise in using shorter oral regimens for drug-resistant tuberculosis, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* The investigator considers that the participant is not able to complete the study process, or the participation is not safe.

Where this trial is running

Hefei, Anhui and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Drug-resistant TuberculosisPulmonary TuberculosisRifampin-resistant TuberculosisDrug-resistant tuberculosisBDLLChinese PopulationShort regimen
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.