Determination of Plasmatic and CSF Levels of High Doses of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Concentration of Micafungin in Blood
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. This study will also evaluate the proportion of success and of failure of the therapy with micafungin among treated neonates and will identify a conversion factor to relate plasma levels of micafungin into capillary and venous blood measured through blood samples from the heel and from a peripheral vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 180 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infection by systemic candidiasis Systemic candidiasis is diagnosed in case of worsening of clinical conditions while on therapy with antibiotics, in case of isolation of candida from at least one sample collected from a normally sterile site (Blood, CSF, Urine, Peritoneal Fluid) and/or from at least two non contiguous sites (tracheal aspirate, gastric aspirate, faeces) and/or positivity to candida through polymerase chain reaction (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 (white blood cell [WBC] ≤5000/mm3 or WBC ≥20.000/mm3, immature to total neutrophil ratio [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/or positivity to test Enzyme Linked Immuno-Sorbent Assay (ELISA) for the mannan antigen (≥125 pg/ml).
- •Neonates affected by candida meningitis and/or hydrocephalus due to candida infection and/or bearing external ventricular derivation, until enrollment of at least 4 subjects with this characteristics.
- •Parents of neonates, or legal representative, able to consent and comply with protocol requirements.
- •Survival expectation not inferior to 3 days.
排除标准
- •Acute hepatopathy (ammonium > 200 µg/dL) or chronic hepatopathy.
- •Known allergy or hypersensitivity to echinocandins or any of the excipients present in the formulation of the investigational product.
研究组 & 干预措施
Micafungin
Participants will receive micafungin 8 mg/kg per day via intravenous infusion for approximately 1 hour. Micafungin will be administered for a minimum of 14 days until 1 of the following conditions applied: •Negative results (absence of Candida growth) from at least 2 consecutive blood cultures and/or resolution of clinical and laboratory symptoms and reduction of mannan antigen blood level (< 125 pg/mL) are obtained. •In case of meningitis, hydrocephalus and external ventricular derivation, negative results (absence of Candida growth) from at least 2 consecutive cerebral spinal fluid (CSF) cultures associated with resolution of clinical and laboratory symptoms. •Interruption (including addition or switch to another antifungal agent or dosage change of micafungin) due to demonstration of therapy failure.
干预措施: Micafungin (Drug)
结局指标
主要结局
Concentration of Micafungin in Blood
时间窗: Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10
Concentration will be determined from the pharmacokinetic (PK) blood samples collected via capillary micro-method (draws from the heel).
Concentration of Micafungin in Cerebral Spinal Fluid (CSF)
时间窗: Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10
Concentration will be determined from the from the CSF samples collected.
次要结局
- Percentage of Participants with a Response at End of Treatment (EOT) - Success of Therapy (SOT)(Up to day 14)
- Comparison of Capillary and Venous Plasma Concentrations of Micafungin(Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10)
- Percentage of Participants with A Response at EOT - Failure of Therapy (FOT)(Up to day 14)
- Number of Participants with Adverse Events (AEs)(From the first dose of study drug administration up 72 hours after the last dose, up to 17 days)