Status:
COMPLETED
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Collaborating Sponsors:
IRCCS, Ospedale Pediatrico Bambino Gesu
Conditions:
Candidiasis, Systemic
Candida Meningitis
Eligibility:
All Genders
1-180 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2018
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03421002
Start Date
May 30 2015
End Date
April 10 2018
Last Update
November 18 2024
Active Locations (2)
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1
Site IT39001
Rome, Italy, 00146
2
Site IT39002
Rome, Italy, 00186