C-STAR Study
Study name: Safety and Efficacy of All Oral Regimens containing Contezolid in the Treatment of Rifampicin-resistant Tuberculosis: a Prospective, Multicenter, Randomized, Open-label, Controlled Clinical Trial
- Study acronym: C-STAR
- Primary sponsor: Beijing Chest Hospital, Capital Medical University
- Secondary sponsor: Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing)
- Study type: Interventional clinical study
- Study objectives: The aim of this study was to systematically evaluate the safety and efficacy of all oral regimens containing Contezolid (CZD) in RR-TB patients with Linezolid (LZD) as a control. Objective: To evaluate the safety and efficacy of all oral regimens containing contezolid in the treatment of rifampicin-resistant tuberculosis (TB) compared with all oral regimens containing linezolid. Secondary objective: To explore the effects of different contezolid and linezolid reduction regimens on safety and efficacy after adverse events or events of intolerance.
- Inclusion criteria:
- Age 18-65 years old, male or female
- Weight ≥40㎏, BMI ≥ 17 ㎏/㎡
- Rifampicin-resistant pulmonary tuberculosis (TB) patients with fluoroquinolone resistance or intolerance were diagnosed after molecular biology and/or phenotypic drug susceptibility tests and sputum culture results were positive for acid-fast bacilli within 60 days
- No previous treatment with Bedaquinoline, contezolid, or linezolid
- For those of childbearing age, consent to continue using contraception throughout treatmen
- Subjects (or their legal representatives/guardians) understand the study procedures and content, sign informed consent, and are willing to participate in the study and comply with treatment and follow-up requirements.
- Exclusion criteria:
- Hematogenous disseminated tuberculosis and severe extrapulmonary tuberculosis (including digestive system tuberculosis, urogenital system tuberculosis, osteoarticular tuberculosis, tuberculous meningitis, etc.)
- Allergic to oxazolidinones or use of monoamine oxidase inhibitors 2 weeks before enrollment
- Severe renal insufficiency (creatinine clearance (CrCl) less than 30 mL/min) or impaired liver function (ALT and/or AST levels 3 times the upper limit of the laboratory reference value)
- Hemoglobin < 90g/L, platelets < 100×109/L, or neutrophil count < 1.5×109/L
- Patients with one of the following cardiovascular history: 1) have a history of arrhythmia and are currently receiving medication 2) The ECG showed that the QTcF interval was > 450 ms 7: 3) History of ventricular arrhythmia 4) tip torsion ventricular tachycardia, associated with the following risk factors, including heart failure, hypokalemia, familial long QT syndrome 5) Other heart conditions that may increase the subject's arrhythmia. Life expectancy ≤6 months
- Life expectancy less than 6 months
- Karnofsky score <60
- Pregnant or lactating women
- Unable to take oral medication
- HIV positive or PLHIV
- Known peripheral neuropathy of grade 3 or higher
- Have participated in, or are currently participating in, another clinical study within 2 months prior to screening
- Patients who were deemed unlikely to complete regular follow-up visits to the study center due to travel restrictions, drug or alcohol abuse, or other reasons
- Patients with any pre-existing laboratory abnormalities or other undefined clinical diagnosis may be adversely affected by participation in the study in the opinion of the investigator.
- Intervention arm (Contezolid containing):
- FQ-S regimen 6LFX(MFX) BDQ CZD(CS)CFZ/12 LFX(MFX) CZD(CS) CFZ
- FQ-R regimen :6BDQ CZD CS CFZ/14 CZD CS CFZ.
- Control arm (Linezolid containing):
- FQ-S regimen 6LFX(MFX) BDQ LZD(CS)CFZ/12 LFX(MFX) LZD(CS) CFZ
- FQ-R regimen :6BDQ LZD CS CFZ/14 LZD CS CFZ
- Sample size: 168 with each arm recruiting 84 participants
- Randomization: parralel randomization in a ratio of 1:1
- Study period: 2024-07-01 to 2026-10-01
- Current status: following up on going, the study expected to be completed on October this year.