Determination of Levels of Micafungin in Neonates Suffering from Systemic Candidiasis and/or Candida meningitis.

Phase 1

• Conditions: Systemic Candidiasis and/or Candida Meningitis; MedDRA version: 17.0Level: LLTClassification code 10027238Term: Meningitis fungal NOSSystem Organ Class: 100000004862; MedDRA version: 17.0Level: HLTClassification code 10027237Term: Meningeal fungal infectionsSystem Organ Class: 100000004852; MedDRA version: 17.0Level: LLTClassification code 10042941Term: Systemic fungal infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003087-20-IT
• Lead Sponsor: IRCCS Ospedale Pediatrico Bambino Gesù

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-26
• Study Completion: 2018-04-10
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified