Tedizolid Neuropathies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Describe cases of tedizolid-induced neurotoxicity.
研究概览
简要总结
Tedizolid is a new oxazolidinone, related to linezolid. It has obtained marketing authorization for the treatment of skin and soft tissue infections. Its potential interest compared to linezolid lies mainly in its better tolerance in the context of more prolonged treatments required in chronic Gram-positive cocci infections such as osteoarticular infections. Indeed, linezolid has hematological toxicity, appearing beyond 10 days of treatment. Due to a lower dosage and lower mitochondrial toxicity, the hematological tolerance of tedizolid is better, even allowing it to be used as a relay from linezolid after the occurrence of hematotoxicity. Another side effect of the oxazolidinone class is the occurrence of optic and peripheral neuropathies observed under linezolid. The pharmacological properties of tedizolid and in vitro and in vivo data suggested a lower risk of neurotoxicity, although a few cases have been published..
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients developing optic or peripheral neuropathy while receiving tedizolid therapy
排除标准
- 未提供
结局指标
主要结局
Describe cases of tedizolid-induced neurotoxicity.
时间窗: The outcome will be measured at the last follow-up visit in 2024, i.e. a maximum of 4 years after the start of the neuropathy.
Retrospective cohort describing neurological side effects occurring under tedizolid. Patients will be identified by cross-referencing data from medical records of the infectious diseases department of the Lyon University Hospital, the prospective database of CRIOAc Lyon recording the side effects of new molecules (including tedizolid), and pharmacovigilance data. Description of patient history and clinical data, and tedizolid prescription methods (dose, duration). Unit of Measure :Number of patients (n)
次要结局
未报告次要终点