Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis Patients With Carbapenem-resistant Infections
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cure rates of infections
研究概览
简要总结
This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.
详细描述
Hemophagocytic lymphohistiocytosis (HLH) is a critical condition characterized by the undue activation of cytotoxic T lymphocytes, natural killer cells, and macrophages, resulting in excessive secretion of infammatory cytokines. Infection is an important trigger for HLH. This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met HLH-2004 diagnostic criteria;
- •Active infection；
- •Empirical treatment with carbapenems did not respond after 72 hours；
- •Age >18 years old, no gender limitation;
- •Ability and willingness to adhere to the study visit schedule and all protocol requirements.
排除标准
- •Other antibiotics should be selected according to the results of drug sensitivity；
- •Systemic antibiotics other than carbapenems are used with 72 hours；
- •Inability to take oral medications due to disease of gastrointestinal tract；
- •Severe liver insufficiency;
- •Expected survival time < 1 month;
- •Pregnant or breasting-feeding women;
- •Allergic to Carrimycin tablets;
- •Active hepatitis B or hepatitis C infection;
- •Patients with HIV infection;
- •Patients with other contraindications considered unsuitable for participation in this study.
研究组 & 干预措施
Carrimycin tablets
Carrimycin tablets
干预措施: Carrimycin tablets (Drug)
结局指标
主要结局
Cure rates of infections
时间窗: 1 week and 2 weeks after initiation of treatment
The percentage of participants having clinical cure
Overall response rate of HLH
时间窗: 2 weeks after treatment
Overall response rate includes complete remission (CR) and partial remission (PR)
次要结局
- Overall Survival(1 years)
- Incidence and Severity of Adverse Events(28 days)
研究者
Zhao Wang
Professor and Head of hematology
Beijing Friendship Hospital