Oral Sudapyridine for treating rifampicin-resistant pulmonary tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III clinical study evaluates the efficacy and safety of Sudapyridine (WX-081) in combination with a background regimen for patients with rifampicin-resistant pulmonary tuberculosis. Approximately 450 participants will be screened and randomized in a 2:1 ratio to receive either Sudapyridine or bedaquiline for 24 weeks, followed by a background regimen period lasting up to 72 weeks. The study employs a randomized, double-blind, active-controlled design to ensure robust data collection on treatment outcomes and safety. A subset of participants will also undergo intensive pharmacokinetic sampling and cardiac safety evaluations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg/m2, and 40kg≤ body weight ≤90kg;

  * For clinically diagnosed patients with tuberculosis whose drug sensitivity test has proved to be at least resistant to rifampicin, phenotypic or molecular drug sensitivity test results within 3 months before the subject signs informed consent can be accepted;
  * Direct sputum smear positive for acid-fast bacilli (AFB at least 1+);
  * Willing to discontinue all previous anti-tuberculosis drugs and accept a 7-day washout period;
  * Non-lactating and pregnant women who agree to use contraception throughout the treatment; Or the male patient's spouse agrees to use contraception throughout the treatment.

Exclusion Criteria:

* • Allergic to any study drug or its ingredients;

  * A history of alcohol dependence or drug abuse;
  * With hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis;
  * Drug susceptibility test before screening showed resistance to more than 4 of the 8 antituberculosis drugs in this study;
  * Have taken Bedaquiline before;
  * HIV-positive patients;
  * Laboratory obvious abnormalities;
  * A history of pointy torsion ventricular tachycardia or cardiac risk factors for pointy torsion ventricular tachycardia;
  * Repeated QTcF intervals \> 450ms; Clinically significant ventricular arrhythmias that may require medical or surgical treatment;
  * Documented cardiovascular diseases;
  * Peripheral neuropathy CTCAE grade 3 or grade 4; Grade 1 or grade 2 neuropathy that the investigator believes is likely to progress/worsen over the course of the study; optic neuritis;
  * Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.

Where it's running

• Beijing Chest Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Chest Hospital affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Enrolling by invitation

Study contacts

• Principal investigator: Naihui Chu, Ph.D — Beijing Chest Hospital affiliated to Capital Medical University
• Study coordinator: Naihui Chu, MD
• Email: dongchu1994@sina.com
• Phone: 010-89509312

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Molecular typing of drug-resistant TB strains in Central Africa

  This study tests the genetic patterns of drug-resistant TB strains in Central Africa to understand transmission and how resistance may affect new treatment regimens.

  Recruiting at 8 sites Centre de Recherche Médicale de Lambaréné · Lambaréné and 7 other locations · NCT07017803

• Monitoring linezolid blood levels to reduce treatment interruptions in rifampin-resistant TB

  This project will test whether checking linezolid blood levels and adjusting doses helps people with rifampin-resistant TB stay on treatment longer.

  Recruiting Albert Einstein College of Medicine · East London, Eastern Cape · NCT06590428

• Quabodepistat-containing regimens for drug-resistant pulmonary tuberculosis

  This will test whether quabodepistat combined with other TB drugs can shorten treatment and be safer for adults and teens with rifampicin-resistant or multidrug-resistant pulmonary TB.

  Recruiting at 33 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Beijing, Beijing Municipality and 41 other locations · NCT07209761

• JDB0131 tablets for drug-resistant pulmonary TB

  This tests two doses of the experimental tablet JDB0131 versus a delamanid-containing regimen in people aged 14–65 with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis over an 8-week treatment period.

  Recruiting at 6 sites Phase 2 WestVac Biopharma Co., Ltd. · Wuhan, Hubei and 6 other locations · NCT07170800

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.