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 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 review approach that combined the assessment of limited clinical efficacy, pharmacokinetics, and safety data from neonates and young infants along with microbiology outcomes and pharmacokinetic data from relevant nonclinical models of candidemia/invasive candidiasis to inform the use of micafungin in pediatric patients younger than 4 months, while communicating areas of remaining uncertainty in labeling.

Clinical profile of fungal sepsis in new born: a tertiary centre experience from Bangladesh

Background: Candida infections are frequent and major causes of septicemia in neonatal intensive care units and are associated with high morbidity and mortality. Low birth weight preterm infants are especially vulnerable to these devastating infections. Material and methods: A prospective observational study was done from May 2013 to June 2014 in SCABU (Special Care Baby Unit) & ICU (Intensive Care Unit) of Dhaka Shishu (Children) Hospital, Dhaka. All neonates admitted with suspected clinical sepsis were analyzed in the study. Among which 30 culture positive candida cases were identified and included in this study. Outcome measures assessed was the incidence of candidemia in our NICU with clinical profiles and associated risk factors. Results: Out of 30 newborns 18 (60%) were preterms, 20% of study population were having a birth weight of <1 kg, 23.3% with a birth weight of 1-1.5 kg and 23.3% with a birth weight of 1.5-2.5 kg. 73.4% of the study population were hospitalized for >1 week. In the study group 56.7% had feed intolerance, 53.3% needed ventilator support, 56.7% had temperature instability, 73.3% had thrombocytopenia 63.3% had apnea and 73.3% had jaundice. The overall survival was 63.3%. Conclusions Low birth weight, prematurity, use of broad spectrum antibiotics, mechanical ventilation and prolonged hospital stay were important risk factors associated with neonatal candidiasis in this study. Thrombocytopenia, feed intolerance, increased requirement for ventilator support, temperature instability, jaundice and apnea were significant clinical parameters noted in babies with culture proven neonatal candidiasis. The overall survival was 63.3% in the study group.

Neonatal candidiasis: clinical spectrum and epidemiology in a tertiary care centre

Background: Candidial infections are a serious problem in neonatal intensive care units (NICU) which increases the mortality and morbidity in addition to increasing health care costs. Confirming the diagnosis by laboratory tests is difficult and a high index of suspicion is required. The objective of this study was to identify the clinical spectrum and epidemiology of neonatal candidiasis in a tertiary care NICU.Methods: The present study was carried out in the NICU of SDM medical college and hospital, Dharwad. All babies who were admitted to NICU and who had positive blood culture for Candida were included in the study. One year Data (1st December 2015 to 31st November 2016) was collected retrospectively from NICU case records. Statistical test used was chi square test.Results: Total admissions to the NICU during the study period were 2591. Blood cultures were positive in 132 babies. Among these, Candidial sepsis was noted in 39.39% (52) babies. Out of the 52 positive fungal cultures, 15 were Candida albicans, 35 were Candida non albicans and 2 were mixed cultures (Candida albicans and non albicans) showing an increasing incidence of non-albicans Candida infections. Among the non albicans Candida, Candida tropicalis and Candida guilliermondii were the predominant species (11 each) followed by Candida famata (6), Candida krusei (6) and Candida parapsilosis (3). Candidial sepsis was seen to be more common among preterm and low birth weight babies. Usage of antibiotics, Total parenteral nutrition (TPN) and mechanical ventilation were common risk factors noted in our study.Conclusions: Systemic Candidiasis is a disease of modern neonatal intensive care. It deserves urgent attention for its prevention as well as effective treatment in order to minimize neonatal morbidity and mortality.