Towards Reducing Resistance and Hematological Toxicity of Linezolid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The study will evaluate and improve the performance of pharmaco-statistical models previously developed in the compassionate use program in patients being treated with linezolid under clinical usage conditions. This study will also develop a sensitive and specific tool that may be used to predict patients at risk of hematological toxicity, based on factors including linezolid concentration and duration of therapy and use these models to better understand the determinants of toxicity with linezolid and define better strategies to manage toxicity or reduce its occurrence.
详细描述
Epidemiologic information to be collected
At baseline (upon signing informed consent), the following information will be collected: Demographic data - age, sex, height, weight, state of birth, previous pathology reports associated with the bacteria the subject has contracted, laboratory results, current medication use, and any other prior medical problems/history. The following outcome measures will be assessed: (a) time to resolution of fever, (b) time to normalization of white blood cell count, (c) time to microbiologic eradication of infection, (d) mortality at 28 days following onset of infection.
Blood work to be collected
Hematological parameters:
Patients included in this study will be required to have blood samples taken to determine their platelet count and hemoglobin at baseline (prior to the first dose of linezolid), weekly whilst receiving linezolid and at end of linezolid treatment. Monitoring of hematological parameters is recommended as part of the standard of care for patients being treated with linezolid for greater than 2 weeks. This information will be collected from the participant's medical record and become part of the research record.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Males or females greater than 18 years of age.
- •All patients will remain in the hospital for pharmacokinetic sampling.
- •All subjects must be on the medication linezolid as part of their standard of care.
排除标准
- •Patients with renal failure who receive peritoneal dialysis, hemodialysis or hemofiltration.
- •Any contraindication to blood sampling