NCT04652050撤回不适用
Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation
Hong Nguyen1 个研究点 分布在 1 个国家开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- PK Sampling-measure amount of drug in system
研究概览
简要总结
This is a single-center, observational study of Tolsura PK sampling in lung transplant recipients
详细描述
Patients who are receiving Tolsura as part of their clinical care will be asked to enroll and EMR data and excess biological samples will be collected
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years of age and older
- •hospitalized at UPMC
- •placed on Tolsura prophylactically by clinical team
- •patients who have had or will have a lung transplant.
排除标准
- •redo lung transplant
- •recipient with dual liver-lung transplant
- •patients with previous history of SOT
- •including other organ transplantation
- •patients with known pre-transplant colonization with moulds resistant to azoles
- •patients with intra-transplant positive cultures for moulds in either transplant recipient or his/her donor
- •patients with a history of hypersensitivity reaction to an azole agent
- •patients who are kept NPO (nothing by mouth, including meds)
- •recipients or donor with HepC PCR positive
研究组 & 干预措施
lung transplants
Lung transplants on Tolsura for infection
干预措施: Tolsura (Drug)
结局指标
主要结局
PK Sampling-measure amount of drug in system
时间窗: one day PK sampling
blood samples around a dosing of Tolsura to determine maximum plasma concentration
次要结局
- rates of infection post treatment with Tolsura(6 months)
研究者
Hong Nguyen
Professor
University of Pittsburgh
研究点 (1)
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