EUCTR2004-001491-39-AT进行中（未招募）不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF MICAFUNGIN (FK463) VERSUS CASPOFUNGIN AS ANTIFUNGAL TREATMENT IN PATIENTS WITH INVASIVE CANDIDIASIS OR CANDIDEMIA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 620
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent of the patient or legally authorized representative, and HIPAA
- •Authorization for U.S. sites, or equivalent privacy language as per national regulations, must be obtained prior to entry. Unconscious / incapable patients may be enrolled provided written informed consent is obtained from the legally authorized representative prior to enrollment.
- •2. Patients must have candidemia or invasive candidiasis, documented by at least one typical clinical sign or symptom and confirmed by fungal culture and/or histology
- •For candidemia or acute invasive candidiasis, a positive culture must be
- •documented from a sample obtained no more than 96 hours prior to the first dose of study medication.
- •For chronic invasive candidiasis, a positive culture within the last 4 weeks prior to
- •randomization is acceptable provided the patient has findings of endophthalmitis
- •or hepatosplenic lesions documented by radiographic imaging and has not received
- •greater than two days of prior systemic antifungal therapy, as defined in exclusion
- •criteria #9, within the last 7 days prior to randomization.
- •- For invasive candidiasis, culture results may be pending at the time of enrollment if histology/cytology reveals yeast.
- •- For candidemia, preliminary evidence of yeast (by staining and microscopy of
- •the blood culture sample) is required to enroll a patient.
- •- A confirmation of Candida species must be obtained within one week after enrollment.
- •3. Patients may be of either gender. Females of childbearing potential must have a
- •negative pregnancy test. A pregnancy test should be performed within 14 days prior
- •to the first dose of study drug.
- •4. Patients 18 years of age or older.
- •5. Patients must have sufficient venous access to permit administration of study
- •medication and monitoring of safety variables.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient is pregnant or nursing. Females of childbearing potential must avoid
- •becoming pregnant while receiving study drug.
- •2. Patients with a Child-Pugh Score > 9. For patients with no findings of ascites or encephalopathy and a total bilirubin < 2 mg/dL, the Child-Pugh score does not need to be calculated.
- •3. Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures only of urine specimens, sputum specimens, bronchoalveolarlavage specimens or samples from indwelling drains.
- •4. Patients with a history of allergy, hypersensitivity, or any serious reaction to the
- •echinocandin class of antifungals.
- •5. Patients previously enrolled into this study.
- •6. Patients with a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical adviser, may create an unacceptable additional risk.
- •7. Patients with a life expectancy of less than five days.
- •8. Patients who have received an echinocandin within one month prior to study entry.
- •9. Patients who have received more than two days of prior systemic antifungal therapy for the current infection.
- •Daily dosing can not exceed the following: 1 mg/kg of body weight of
- •amphotericin B, 5 mg/kg of a lipid amphotericin B formulation, 800 mg of
- •fluconazole, 400 mg of itraconazole, or 12 mg/kg of body weight of voriconazole.
- •Combination antifungal therapy is not allowed.
- •Patients may have received prophylaxis with azoles or systemic amphotericin B
- •products without time restrictions.
- •10. Patients with yeast or mold-like infection other than invasive candidiasis or candidemia.
- •11. Patients receiving cyclosporine.
- •12. Patients known, at time of study entry or within 72 hours post randomization, to have Candida endocarditis, Candida osteomyelitis, or Candida meningitis.
研究者
相似试验
进行中（未招募）
不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF MICAFUNGIN (FK463) VERSUS CASPOFUNGIN AS ANTIFUNGAL TREATMENT IN PATIENTS WITH INVASIVE CANDIDIASIS OR CANDIDEMIAInvasive candidiasis or candidemiaMedDRA version: 7.0Level: PTClassification code 10042938EUCTR2004-001491-39-CZAstellas Pharma US, Inc.620
进行中（未招募）
1 期
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF MICAFUNGIN (FK463) VERSUS CASPOFUNGIN AS ANTIFUNGAL TREATMENT IN PATIENTS WITH INVASIVE CANDIDIASIS OR CANDIDEMIAInvasive candidiasis or candidemiaMedDRA version: 7.0 Level: PT Classification code 10042938EUCTR2004-001491-39-GBAstellas Pharma US, Inc.620
进行中（未招募）
1 期
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF MICAFUNGIN (FK463) VERSUS CASPOFUNGIN AS ANTIFUNGAL TREATMENT IN PATIENTS WITH INVASIVE CANDIDIASIS OR CANDIDEMIAInvasive candidiasis or candidemiaMedDRA version: 7.0Level: PTClassification code 10042938EUCTR2004-001491-39-ESFujisawa Healthcare, Inc620
进行中（未招募）
不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF MICAFUNGIN (FK463) VERSUS CASPOFUNGIN AS ANTIFUNGAL TREATMENT IN PATIENTS WITH INVASIVE CANDIDIASIS OR CANDIDEMIAEUCTR2004-001491-39-BEFujisawa Healthcare, Inc620
招募中
3 期
A RANDOMIZED, DOUBLE-BLIND, PHASE 3 COMPARISON OF PLATINUM-BASED THERAPY WITH TSR 042 AND NIRAPARIB VERSUS STANDARD OF CARE PLATINUM-BASED THERAPY AS FIRST LINE TREATMENT OF STAGE III OR IV NONMUCINOUS EPITHELIAL OVARIAN CANCERovarian canceradenocarcinoma10033283NL-OMON54558TESARO, Inc.38