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临床试验/NCT00083343
NCT00083343已完成2 期

A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in the Treatment of Adults With Invasive Candida Infections (Excluding Patients With Candidemia as the Sole Site of Infection)

Merck Sharp & Dohme LLC0 个研究点目标入组 48 人开始时间: 2004年5月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
48
主要终点
Favorable overall response rate

研究概览

简要总结

Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within 96 hours of the study entry.
  • The patient must also have clinical evidence of Candida infection (e.g., oral temperature >100 degrees Fahrenheit, signs of inflammation from infected site, systolic blood pressure <90) within 96 hours of study entry.
  • The patient must be at least 18 years old, and if a woman of child bearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment.

排除标准

  • Patients whose only site of Candida infection was the bloodstream.

结局指标

主要结局

Favorable overall response rate

次要结局

  • Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy
  • Favorable overall response rate on Day 10 of caspofungin therapy

研究者

申办方类型
Industry
责任方
Sponsor

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