NCT02227797已完成1 期
MT2013-37R: Voriconazole Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups
研究概览
简要总结
The primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent)
- •Age ≤ 21 years
- •Adequate organ function within 14 days of enrollment, i.e. Creatinine: < 1.5 x ULN and Hepatic: ALT, AST and total bilirubin < 3 x ULN
- •Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation
排除标准
- •Has received voriconazole within 5 days prior to starting study therapy
- •History of hypersensitivity or severe intolerance to azoles
- •History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec
- •Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.
- •Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates.
- •Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism
- •Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure
研究组 & 干预措施
Voriconazole
Experimental
干预措施: Voriconazole (Drug)
结局指标
主要结局
Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups
时间窗: Seven days after starting voriconazole
次要结局
- Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups(After starting voriconazole: Day 5, between Days 12-15, between Days 19-22)
- Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes(After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42)
- Incidence of fungal infection(6-month period after transplant)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous LeukemiaLeukemia, Myelocytic, AcuteNCT00152594University of Cologne150
进行中（未招募）
不适用
Dosing of voriconazole according to the package leaflet compared with dosing voriconazole based on measured voriconazole concentrations in blood.EUCTR2008-007973-19-DEniversity Medical Center Groningen192
进行中（未招募）
不适用
Pharmacologic optimization of voriconazole - a prospective clustered group-randomized cross-over trial of therapeutic drug monitoringThe objective of this prospective stratified cluster randomized cross-over trial is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved outcome in patient with haematological malignancies (efficacy and safety) and is more cost-effective compared to the current standard of care.EUCTR2008-007973-19-NLniversity Medical Center Groningen192
终止
3 期
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In ChildrenInvasive AspergillosisNCT00836875Pfizer31
已完成
3 期
Pharmacologic Optimization of VoriconazoleInvasive Fungal InfectionHematological MalignancyNCT00893555Jan-Willem C Alffenaar189