Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease
概览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Beijing Chest Hospital
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time To Positivity in sputum cultures
概览
简要总结
This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Patients were administered contezolid monotherapy for 14 days specifically targeting Mycobacterium abscessus, and were compared to a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug. The comparison was conducted through the analysis of colony forming units counts and Time To Positivity in sputum cultures. By evaluating the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus infections, this study aimed to assess the early bactericidal activity of contezolid, thereby providing a basis for the selection of new therapeutic options for the treatment of patients with Mycobacterium abscessus infections.
详细描述
As one of the drugs for treating Mycobacterium abscessus infections, linezolid is effective but its use is limited in anti-Mycobacterium abscessus treatment regimens due to the high incidence of adverse reactions associated with long-term use. Contezolid, a new drug developed in China, belongs to the oxazolidinone class of drugs and shares a similar antibacterial spectrum with linezolid, while exhibiting a significantly better safety profile. This study is a single-center, randomized, controlled, open-label clinical trial designed to evaluate the early bactericidal activity. It enrolls patients with Mycobacterium abscessus disease and administers a 14-day monotherapy of contezolid for the treatment of the disease. The study compares contezolid with linezolid, a classic anti-Mycobacterium abscessus drug, by analyzing colony forming units and Time To Positivity in sputum cultures. By assessing the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus disease, the study evaluates the early bactericidal activity of contezolid, providing a basis for the selection of new therapeutic options for the treatment of Mycobacterium abscessus disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18 and 65 years old;
- •Weight ranging from 40 kg to 90 kg;
- •At least one positive sputum culture for Mycobacterium abscessus within 6 months prior to screening, and one positive sputum culture for Mycobacterium abscessus with molecular species identification during the screening period within 1 month prior to the study;
- •Voluntary participation in this study and signing of the informed consent form; (5) Male and female participants must use effective contraception during the study and for 1 month after the study ends.
排除标准
- •Patients who have been on long-term corticosteroid therapy or taking immunosuppressants within 90 days prior to screening;
- •Pregnant women, postpartum women, and lactating patients;
- •Patients with a history of bedaquiline allergy or known hypersensitivity, or a history of severe adverse reactions;
- •Patients with evidence of bedaquiline resistance;
- •Patients deemed unsuitable for participation in this study by the investigator's assessment;
- •Patients whom the investigator believes participation in this study would harm their health, or who are unlikely to comply with the scheduled visits and assessments as outlined in the protocol, and therefore are not suitable for participation in this study.
研究组 & 干预措施
Contezolid group
Contezolid 800mg twice daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of contezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity.
干预措施: Contezolid (Drug)
Linezolid group
Linezolid 600mg once daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of linezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity.
干预措施: linezolid (Drug)
结局指标
主要结局
Time To Positivity in sputum cultures
时间窗: 14 days
With a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, then were compared with a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug, through analysis and comparison of Time To Positivity in sputum cultures.
次要结局
未报告次要终点
研究者
Nie WenJuan
chief physician
Beijing Chest Hospital