Abstract | BACKGROUND:
Invasive fungal infections are responsible for significant morbidity and mortality. Safety and effectiveness of antifungal agents is a particular concern in pediatric populations, where data are often limited. Micafungin is an echinocandin with demonstrated antifungal activity against a wide spectrum of Candida spp.; this subanalysis of data from the MYRIADE study describes the use of micafungin and its therapeutic outcomes in pediatric patients, in normal clinical practice. METHODS: MYRIADE was an observational, multicenter, national, prospective, longitudinal study conducted from January 2010 to December 2012, in patients treated with micafungin using a prophylactic or curative strategy, across 17 sites [oncohematology (n = 8), neonatal intensive care units (ICUs) (n = 5) and pediatric ICUs (n = 4)]. The treatment regimen, the achievement of the therapeutic objective and the tolerance were reported. RESULTS: The study population consisted of 110 pediatric patients (31 neonates, 24 children <2 years old and 55 children ≥2 to <16 years old). The therapeutic objective was achieved in 49/64 (76.6%) oncohematology patients, 28/29 (96.6%) neonatal ICU patients and 12/14 (85.7%) pediatric ICU patients. Twenty-four (21.8%) children developed an adverse event (AE); more AEs were observed in oncohematology patients compared with ICU patients [17 (26.1%) vs. 7 (15.6%)]. Only one serious AE, reported in an oncohematology patient, was considered related to micafungin. CONCLUSIONS: In the first large observational study of micafungin treatment or prophylaxis conducted under real-world conditions in France, micafungin was effective and well tolerated for prophylaxis of invasive fungal infections in pediatric oncohematology patients and for curative purposes in pediatric and neonatal ICU patients.
|
Authors | Guy Leverger, Jean-François Timsit, Noël Milpied, Bertrand Gachot |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 38
Issue 7
Pg. 716-721
(07 2019)
ISSN: 1532-0987 [Electronic] United States |
PMID | 31192976
(Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antifungal Agents
- Micafungin
|
Topics |
- Adolescent
- Antifungal Agents
(administration & dosage, adverse effects)
- Candida
(isolation & purification)
- Candidiasis, Invasive
(drug therapy, prevention & control)
- Chemoprevention
(adverse effects, methods)
- Child
- Child, Preschool
- Drug-Related Side Effects and Adverse Reactions
(epidemiology)
- Female
- France
- Humans
- Infant
- Infant, Newborn
- Longitudinal Studies
- Male
- Micafungin
(administration & dosage, adverse effects)
- Prospective Studies
- Treatment Outcome
|