Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT03421002
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
180 Days
Study:
NCT03421002
Study Brief:
Protocol Section:
NCT03421002