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enero 18, 2021

A Regulatory Review Approach for Evaluation of Micafungin for Treatment of Neonatal Candidiasis

Pathogenesis of neonatal candidiasis (NC) is distinct from systemic candidiasis in adults and older pediatric patients due to the significant incidence of central nervous system (CNS) involvement in neonates. Thus, although adequate and well-controlled trials in NC are often unfeasible due to difficulty enrolling patients, extrapolation of efficacy from antifungal drug trials in adults is generally not appropriate. However, treatment of NC is an area of great unmet need. We describe a regulatory…

Wickerhamomyces anomalous: A Rare Cause of Fungemia Causing Febrile Neutropenia in Acute Lymphoblastic Leukemia

Candida bloodstream infection is the major cause of increased morbidity and mortality (20-49%) in hospitalized patients in both paediatric and adult age groups. Due to the increase in the number of immunocompromised patients, other important species such as Trichosporon asahii and Debaryomyces hansenii are emerging. One such organism, Wickerhamomyces anomalous, previously known as Pichia anomala (teleomorph stages of several Candida species), is increasingly being reported as a cause of fungemia…

Imipenem and Cilastatin

Limited information indicates that imipenem produces low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally disruption of the infant’s gastrointestinal flora, resulting in diarrhea or thrush has been reported with beta-lactams, but these effects have not been adequately evaluated. Imipenem-cilastatin and imipenem-cilastatin-relebactam are acceptable in nursing mothers.