NCT00002339已完成3 期
An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 100
- 试验地点
- 4
研究概览
简要总结
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
详细描述
Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •AIDS or other immunocompromising condition.
- •Candidal esophagitis.
- •Life expectancy of at least 2 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Evidence of non-candidal systemic fungal infection.
- •Abnormalities that may preclude esophagoscopy or endoscopy.
- •Unable to tolerate fluconazole.
- •Unable to give informed consent.
- •Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor).
- •Other condition that would make patient unsuitable for enrollment.
- •Concurrent Medication:
- •Concomitant oral or topical antifungal agent.
- •Other experimental medications.
- •Patients with the following prior condition are excluded:
- •History of allergy to imidazoles or azoles.
- •Prior Medication:
- •Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.
研究者
研究点 (4)
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