FLUCONAZOLE PROPHYLAXIS FOR THE PREVENTION OF CANDIDIASIS IN INFANTS 750 GRAMS

用于预防婴儿念珠菌病的氟康唑预防剂 750 克

• 批准号: 8356710
• 负责人: MOHAN VENKATESH
• 金额: $ 0.21万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356710
• 关键词: Age; Blood specimen; Candida; Candidiasis; Caring; Cessation of life; Clinical Research; Dose; Drug Kinetics; Enrollment; Exhibits; Fluconazole; Funding; Fungal Drug Resistance; Genetic Variation; Grant; Infant; Infection; Monitor; National Center for Research Resources; Nature; Neurodevelopmental Impairment; Outcome; Pharmaceutical Preparations; Placebos; Premature Infant; Prevention; Principal Investigator; Prophylactic treatment; Research; Research Infrastructure; Resources; Risk; Safety; Sampling Studies; Source; Survivors; Time Study; United States National Institutes of Health; cost; design; dosage; follow-up; improved; neonate; neurodevelopment; prevent

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT This study is designed to assess whether fluconazole prophylaxis will decrease death or candidiasis among infants most at risk for candidiasis, those 750g. This study will monitor for safety while on study drug until death or discharge from the NICU. In addition neurodevelopment will be assessed in the surviving infants at 18-22 months. The multi-center nature of this trial will help control for variability in rates of candidiasis between centers due to different care practices. Total study time will be 3 years--18 months for enrollment and 18 months corrected age for neurodevelopmental follow-up. I. HYPOTHESIS Floconazole prophylaxis will decrease death or candidiasis among infants most at risk for candidiasis, those 750g. II. SPECIFIC AIMS OBJECTIVES AIM 1: Determine if fluconazole prevents death or candidiasis in premature infants Hypothesis 1: Fluconazole prophylaxis will result in an absolute reduction of 15% in death or candidiasis in neonates born less than 750g. AIM 2: Determine effect of fluconazole prophylaxis on neurodevelopmental impairment Hypothesis 2: Fluconazole prophylaxis will result in improved neurodevelopmental outcomes in survivors at 18-22 months corrected age AIM 3: Determine the safety and pharmacokinetics of fluconazole Hypothesis 3: A fluconazole dose of 6 mg/kg twice weekly will be a safe and appropriate dosage. AIM 4: Evaluate antifungal resistance due to fluconazole prophylaxis Hypothesis 4: There will be no difference in MIC between isolates from infants receiving placebo and fluconazole. AIM 5: Collect scavenged blood sample for studies of associations between genetic variation in infants who develop Candida infections and those who dont. Hypothesis 5: Infant who develop Candida infections will exhibit genetic variation when compared to infant who do not develop Candida infections.

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 摘要 这项研究旨在评估氟康唑预防是否会降低死亡率或 念珠菌病在最有可能患念珠菌病的婴儿中，那些750克。这项研究将监测研究药物的安全性，直到死亡或从NICU出院。此外 存活的18-22个月的婴儿将接受神经发育评估。这项试验的多中心性质将有助于控制不同中心之间由于不同护理实践而导致的念珠菌病发病率的变异性。总研究时间为3年--入学为18个月，神经发育随访为18个月。 一、假说 氟康唑预防将减少最有可能患念珠菌病的婴儿的死亡或念珠菌病，这些婴儿的体重为750克。 二、具体目标 目标 目的1：确定氟康唑能否预防早产儿的死亡或念珠菌病假设1：预防氟康唑将使出生体重小于750克的新生儿的死亡或念珠菌病的发生率绝对降低15%。 目的2：确定氟康唑预防对神经发育障碍的影响假设2：氟康唑预防将改善18-22个月校正年龄的幸存者的神经发育结果 目的3：确定氟康唑假说的安全性和药代动力学3：氟康唑剂量为6 mg/kg，每周两次，是安全和合适的剂量。 目的：评估氟康唑预防对真菌的耐药性假说4：接受安慰剂和氟康唑的婴儿分离株的MIC没有差异。 目的5：收集清除的血液样本，用于研究感染念珠菌的婴儿和没有感染念珠菌的婴儿之间的遗传变异之间的关系。假设5：与未感染念珠菌的婴儿相比，感染念珠菌的婴儿会表现出遗传变异。