PER-076-09已完成未知
PHASE 3, RANDOMIZED, DOUBLE BLIND, MULTIETRIC STUDY TO COMPARE THE EFFECTIVENESS AND SAFETY OF MICAFUNGINE AGAINST ANOPHOTHICIN B DEOXYCOLATE FOR THE TREATMENT OF NEONATAL CANDIDIASIS.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 年龄范围
- 0 至 0（—）
入选标准
- •Prior to admission, informed written consent of the legally authorized representative and authorization under HIPAA for centers in the US must be obtained. UU. or the equivalent privacy language in accordance with national standards.
- •Infants must be between 48 hours of life and 120 days of life at the time of obtaining the crop.
- •Diagnosis of invasive candidiasis
- •The infant must have sufficient venous access to allow the administration of the study medication and the monitoring of the safety variables.
排除标准
- •Infants with a history of any hypersensitivity reaction or severe vasomotor reaction to any echinocandin or systemic product with amphotericin B.
- •Infants who have received more than 48 hours of systemic antifungal treatment before the first dose of the study drug for the treatment of current Candida infection. Cumulative doses should not exceed 2 mg / kg of CAB. In the case of a systemic antifungal treatment not specified here, infants who have received more than 2 therapeutic doses within 48 hours prior to the first dose of the study drug will not be eligible.
- •Infants who have a regrowth of systemic mycosis while receiving a product with amphotericin B or an echinocandin as a prophylaxis.
- •Infants who have failed previous antifungal treatment for this episode of invasive candidiasis, including recurrence of the same Candida infection within 2 weeks of the end of antifungal treatment.
- •Infants with a concomitant medical condition, whose participation, in the opinion of the researcher and / or the medical advisor, may create an additional unacceptable risk.
- •Infants enrolled previously in this study.
- •Infants coinfected with a fungal organism not belonging to the genus Candida.
- •Infants whose positive cultures of yeast fungi have been obtained exclusively from a permanent catheter in the bladder or sputum.
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