5 results
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
see protocol summary
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…