EUCTR2014-003087-20-IT进行中（未招募）1 期
Determination of Plasmatic and CSF Levels Of High Doses Of Micafungin in Neonates Suffering from Systemic Candidiasis and/or Candida meningitis.
IRCCS Ospedale Pediatrico Bambino Gesù0 个研究点目标入组 35 人开始时间: 2014年8月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- •1.Infection by systemic Candidiasis, definite or suspected.
- •a)Definite systemic Candidiasis is diagnosed in case of isolation of Candida from at least one sample collected from a normally sterile site (Blood, CSF, Urine, Peritoneal Fluid) and/or positivity to Candida through PCR (Septifast test), associated with at least one clinical symptom (fever or hypothermia, mottled skin, feeding difficulties, muscular hypotonia or hypertonia, apnoea crisis, bradycardia, tachycardia, hypotension, dyspnea, polypnea, desaturation) and one laboratory symptom (WBC =5000/mm3 or WBC =20.000/mm3, I/T ratio >2, Platelet count =100.000/mm3, C-reactive Protein >0,5 mg/dL, Standard Base Excess >-7 mmol/L, CSF pleocytosis-cells = 6).
- •b)Suspected systemic Candidiasis is diagnosed in case of worsening of clinical conditions while on therapy with antibiotics, isolation of Candida from at least two non contiguous sites (tracheal aspirate, gastric aspirate, faeces) associated with at least one clinical symptom (fever or hypothermia, mottled skin, feeding difficulties, muscular hypotonia or hypertonia, apnoea crisis, bradycardia, tachycardia, hypotension, dyspnea, polypnea, desaturation) and one laboratory symptom (WBC =5000/mm3 or WBC =20.000/mm3, I/T ratio >2, Platelet count =100.000/mm3, C-reactive Protein >0,5 mg/dL, Standard Base Excess >-7 mmol/L, CSF pleocytosis-cells = 6) and positivity to test ELISA for the mannan antigen (=250 pg/ml).
- •2.Neonates affected by definite or suspected Candida meningitis and/or hydrocephalus due to Candida infection and/or bearing external ventricular derivation, until enrolment of 4 subjects with this characteristics.
- •3.Parents of neonates, or their legal representative, able to consent and comply with protocol requirements.
- •4.Survival expectation not inferior to 3 days.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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
- •1.Hepatic acute or chronic insufficiency with at least one of the following abnormal parameters:
- •a.Ammonium > 85 µg/dL
- •b.ALT/GPT > 40 UI/L
- •c.AST/GOT > 40 UI/L
- •d.Direct Bilirubin > 2mg/dL
- •2.Baseline INR >5%
- •3.Known allergy or hypersensitivity to echinocandins or any of the excipients present in the formulation of the IMP.
- •4.Micafungin infusion already started.
- •5.Neonates affected by definite or suspected Candida meningitis and/or hydrocephalus due to Candida infection and/or bearing external ventricular derivation, if already 4 subjects with this characteristics have been enrolled into the study.
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