NCT00002277已完成3 期
Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 3
研究概览
简要总结
To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Immunostimulants under studies carried out under an IRB approved protocol.
- •Treatments of intercurrent non-fungal infection.
- •Allowed but requires monitoring during fluconazole therapy:
- •Barbiturates.
- •Phenytoin.
- •Oral hypoglycemics.
- •Coumarin-type anticoagulants.
- •Patients must have the following:
- •Diagnosis or presumption of fungal infection under defined conditions.
- •Written informed consent either from the patient or the patient's legal guardian.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Burns > 30 percent of the body.
- •Diagnosis of AIDS or AIDS related complex (ARC).
- •HIV positive unless they have a malignancy.
- •History of allergy to or intolerance of imidazoles or azoles.
- •Moderate to severe liver disease as defined by specific lab values.
- •Unlikely to survive more than 24 hours.
- •Evidence of previous amphotericin B sensitivity.
- •Concurrent Medication:
- •Concomitant antifungal agents other than the study drugs.
- •Immunostimulants, except for studies carried out under an IRB approved protocol.
- •Concurrent Treatment:
- •Lymphocyte replacements.
- •Patients with the following are excluded:
- •Defined disease conditions listed in Exclusion Co-Existing Conditions.
- •Unlikely to survive more than 24 hours.
- •Previous participation in this study; reentry for the same infection is not allowed.
- •Known to be unable to take amphotericin B due to acute toxicities.
- •Prior Medication:
- •Previous fluconazole therapy for this infection.
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal MeningitisMeningitis, CryptococcalHIV InfectionsNCT00002068Pfizer
已完成
不适用
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal MeningitisMeningitis, CryptococcalHIV InfectionsNCT00002075Pfizer
已完成
不适用
A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal MeningitisMeningitis, CryptococcalHIV InfectionsNCT00002305Pfizer
已完成
不适用
Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal MeningitisMeningitis, CryptococcalHIV InfectionsNCT00000708National Institute of Allergy and Infectious Diseases (NIAID)120
已完成
不适用
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency SyndromeMeningitis, CryptococcalHIV InfectionsNCT00002074Pfizer