NCT00002041已完成不适用
Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded.
- •Concurrent Medication:
- •Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
- •Patients with the following are excluded:
- •Documented Candida fungemia.
- •Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis.
- •Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
- •Patient refusal to enter study.
- •Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis.
- •Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy.
- •Informed consent must be signed and obtained.
排除标准
- 未提供
研究者
研究点 (1)
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