A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis - MAGIC-2

Astellas Pharma Global Development, Inc.0 个研究点目标入组 225 人开始时间: 2012年6月1日最近更新: 2015年7月10日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Astellas Pharma Global Development, Inc.
入组人数: 225

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Subject is eligible for the study if all of the following apply:
•1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
•2. Infant greater than 48 hours of life up to DOL 120 at the time of culture acquisition.
•3. Diagnosis of invasive candidiasis by one of the following (see Appendix 1 for Site-Specific Diagnostic Criteria):
•a. Proven Candidemia: One positive blood culture collected within 4 days prior to the first dose of study drug.
•b. Proven Candiduria: One positive urine fungal culture obtained within 4 days prior to the first dose of study drug by I/O catheterization or suprapubic aspiration. Positive fungal culture must show greater than or equal to 1000 CFU/mL in a single urine culture collected via I/O catheterization or greater than or equal to 100 CFU/mL in a single urine culture collected via suprapubic aspiration.
•c. Proven Candida Meningitis: The presence of Candida species in CSF culture obtained within +/- 4 days from the first dose of study drug.
•d. Candida – Other focus:
•i. Positive tissue biopsy or positive culture from a normally sterile body fluid obtained within 4 days prior to the first dose of study drug, or
•ii. Positive culture for Candida (or yeast) from a new drain placed within the last 7 days prior to the first dose of study drug in a normally sterile site. Culture must have been obtained at the time of drain placement or within 1 day after drain placement. NB: Culture results to confirm Candida species may be pending at the time of enrollment if the following criteria are met:
•- For candidemia, staining/microscopy of the blood culture sample reveals preliminary evidence of yeast.
•- For invasive candidiasis other than candidemia, histology/cytology reveals findings consistent with yeast.
•Note: All Candida organisms must be speciated.
•4. Infant must have sufficient venous access to permit administration of study medication and monitoring of safety variables.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 225
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Subject will be excluded from participation if any of the following apply:
•1. Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or systemic amphotericin B product.
•2. Infant who has received more than 48 hours of systemic antifungal therapy prior to the first dose of study drug for treatment of the current Candida infection. Cumulative doses must not exceed 2 mg/kg of CAB. For systemic antifungal therapy not specifically stated here,
•infants with more than 2 therapeutic daily doses within the 48 hours prior to the first dose of study drug will not be eligible.
•3. Infant who has a breakthrough systemic fungal infection while receiving an amphotericin B product or an echinocandin as prophylaxis.
•NOTE: Infants with a breakthrough fungal infection while receiving azole prophylaxis will be eligible for enrollment.
•4. Infant who has failed prior systemic antifungal therapy for this episode of invasive candidiasis, including recurrence of the same Candida infection within 2 weeks of completing systemic antifungal therapy.
•5. Infant with a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
•6. Infant previously enrolled in this study.
•7. Infant who is co-infected with a non-Candida fungal organism.
•8. Infant whose positive yeast cultures are solely from an indwelling bladder catheter or sputum.

研究者

发起方

Astellas Pharma Global Development, Inc.

相似试验

进行中（未招募）

1 期

Adults With Complicated Urinary Tract Infections including infection reaching their kidneys will be treated with either cefepime in combination with AAI101 or Piperacillin/Tazobactam. Neither the participants nor the research staff know the identity of the administered drug. cefepime/AAI101 or Piperacillin/Tazobactam alone will be assigned using a method based on chance.Complicated urinary tract infections including acute pyelonephritisMedDRA version: 20.1Level: PTClassification code 10037597Term: Pyelonephritis acuteSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestations

EUCTR2017-004868-35-BGAllecra Therapeutics SAS1,044

进行中（未招募）

不适用

Trial to Compare the Efficacy and Safety of Micafungin versus Amphotericin B Deoxycholate to Treat Neonatal Candidiasiseonatal Candidiasis

EUCTR2012-000780-24-HUAstellas Pharma Global Development, Inc.225

进行中（未招募）

1 期

EUCTR2017-004868-35-LTAllecra Therapeutics SAS1,044

进行中（未招募）

1 期

EUCTR2017-004868-35-ESAllecra Therapeutics SAS1,044

进行中（未招募）

不适用

Trial to Compare the Efficacy and Safety of Micafungin versus Amphotericin B Deoxycholate to Treat Neonatal Candidiasiseonatal Candidiasis

EUCTR2012-000780-24-BGAstellas Pharma Global Development, Inc.225