Health Trials

About this trial

This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.

Eligibility criteria

Qualifiers

Age: 14 years through 65 years of age, male or female

Weight: 40kg ≤ weight ≤ 90kg

Patients with clinically confirmed pulmonary tuberculosis, Drug Susceptibility Testing (DST) results confirmed to be at least rifampicin-resistant, molecular or phenotypic DST results within 3 months before enrollment can be received

Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)

Disqualifiers

Those who cannot take delamanid, bedaquiline, or linezolid for various reasons

Take delamanid, bedaquiline, or linezolid for more than 1 month (can be enrolled if evidence of no resistance to the above drugs is provided)

Hematogenously disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator; or patients with pulmonary tuberculosis who are assessed by the investigator to be likely to require surgical treatment within 8 weeks

History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or bradycardia

Trial design

Treatments tested in this trial

  • JDB0131 100mg
  • JDB0131 200mg
  • Delamanid (D)

Treatment groups

60 Participants
are divided into 3 treatment groups

Locations

7
Wuhan Pulmonary Hospital WuhanHubei, China
Changsha Central Hospital ChangshaHunan, China
The Second Hospital of Nanjing NanjingJiangsu, China
Shandong Public Health Clinical Center JinanShandong, China

Sponsors and collaborators

WestVac Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov