NCT00066599已完成2 期
An Open-Label, Intravenous To Oral Switch, Multiple Dose, Multi-Center Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Hospitalized Children Aged 2 - <12 Years Who Require Treatment For The Prevention Of Systemic Fungal Infection
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 7
研究概览
简要总结
RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic fungal infections in children who have neutropenia after receiving chemotherapy for leukemia, lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.
详细描述
OBJECTIVES:
- Determine the pharmacokinetics of voriconazole administered IV and orally for the prevention of systemic fungal infection in pediatric patients with neutropenia after chemotherapy.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a pilot, open-label, multicenter study. Patients are stratified according to age (2 to 5 vs 6 to 11).
Within 48 hours after completion of chemotherapy, patients begin prophylactic therapy:
- Cohort 1 (the first 18 patients, 9 per stratum): Patients receive voriconazole IV over 80-160 minutes twice daily on days 1-8 and oral voriconazole* twice daily beginning on day 9.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Expected to develop neutropenia (absolute neutrophil count less than 500/mm^3) lasting for more than 10 days after chemotherapy for 1 of the following conditions:
- •Aplastic anemia
- •Preparation for a bone marrow or stem cell transplantation
- •Requiring treatment for the prevention of systemic fungal infection
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •See Disease Characteristics
- •AST and ALT no greater than 5 times upper limit of normal (ULN)
- •Bilirubin no greater than 5 times ULN
- •Creatinine clearance at least 30 mL/min
- •Cardiovascular
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •No severe hypokalemia (potassium less than 3.2 mmol/L)
- •No prior hypersensitivity to or severe intolerance of azole antifungal agents
- •No other concurrent condition that would preclude study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 24 hours since prior use of any of the following:
- •Terfenadine
- •Quinidine
- •Astemizole
- •Cisapride
- •Omeprazole
- •More than 14 days since prior use of any of the following:
- •Rifabutin
- •Carbamazepine
- •Phenytoin
- •Nevirapine
- •Long-acting barbiturates
- •No prior sirolimus
- •No prior enrollment on this study
- •No concurrent use of any of the following:
- •Terfenadine
- •Quinidine
- •Astemizole
- 另有 7 项未显示
排除标准
- 未提供
研究者
研究点 (7)
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