NCT00002304已完成不适用
A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 82
研究概览
简要总结
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
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
- •Prior Medication:
- •Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Evidence of noncandidal systemic fungal infections.
- •Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
- •Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
- •Leukemia requiring chemotherapy.
- •Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.
- •Concurrent Medication:
- •Warfarin.
- •Immunostimulants.
- •Interferon.
- •Oral or topical antifungal agents.
- •Concurrent Treatment:
- •Lymphocyte replacement.
- •Patients with the following are excluded:
- •History of allergy to imidazoles.
- •Abnormalities which may preclude esophagoscopy or endoscopy before or during the study.
- •Inability to tolerate fluconazole or ketoconazole.
- •Inability or unwillingness to give written informed consent.
- •Life expectancy < 2 months.
- •Prior Medication:
- •Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole.
- •Warfarin.
- •Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia.
- •Illicit or illegal drug use.
研究者
研究点 (82)
Loading locations...
相似试验
已完成
不适用
A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDSCandidiasis, OralHIV InfectionsNCT00002282Pfizer
已完成
3 期
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)MycosesCandidiasisHIV InfectionsNCT00000676National Institute of Allergy and Infectious Diseases (NIAID)500
已完成
不适用
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency SyndromeCandidiasis, OralHIV InfectionsNCT00002112Pfizer
撤回
4 期
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic PatientsSepsisCandidiasisNCT00304772Kyoto University
终止
3 期
High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and ManausCutaneous LeishmaniasisNCT01953744Hospital Universitário Professor Edgard Santos53