The Pharmacokinetics and Safety of Micafungin, a Novel Echinocandin, in Premature Infants
| Autor: | Donald N. Buell, Gloria P Heresi, John N. van den Anker, Laura L. Kovanda, James Keirns, Gregory L. Kearns, Michael D. Reed, Dale R. Gerstmann, Jeffrey L. Blumer |
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| Rok vydání: | 2006 |
| Předmět: |
Male
Microbiology (medical) Pediatrics medicine.medical_specialty Antifungal Agents Echinocandin Metabolic Clearance Rate Lipoproteins Infant Premature Diseases Pharmacology Peptides Cyclic Cell wall synthesis Echinocandins Lipopeptides Pharmacokinetics Sepsis Metabolic clearance rate medicine Humans biology business.industry Candidiasis Infant Newborn Micafungin Infant Pneumonia bacterial infections and mycoses Low birth weight Infectious Diseases Multicenter study Enzyme inhibitor Injections Intravenous Pediatrics Perinatology and Child Health biology.protein Female medicine.symptom business Infant Premature Half-Life medicine.drug |
| Zdroj: | The Pediatric Infectious Disease Journal. 25:1110-1115 |
| ISSN: | 0891-3668 |
| DOI: | 10.1097/01.inf.0000245103.07614.e1 |
| Popis: | Candidal fungal infection rates in neonates are increasing and are a significant cause of mortality, especially in low birth weight infants. Micafungin is an echinocandin that works by inhibiting 1,3-beta-D-glucan synthase, an enzyme responsible for fungal cell wall synthesis. The objective of this study was to determine the safety and pharmacokinetics of micafungin in premature infants.: This was a phase I, single-dose, multicenter, open-label, sequential-dose trial of intravenous micafungin investigating 3 doses (0.75 mg/kg, 1.5 mg/kg and 3.0 mg/kg) in 18 premature infants weighing1000 g (n = 6 in each dosage group). A further 5 infants (500-1000 g) were enrolled in the 0.75 mg/kg dosage group only.: The mean +/- standard deviation gestational age in the1000 g dosage group was 26.4 +/- 2.4 weeks and, on entry, patients had one or more of a variety of underlying conditions, including sepsis, pneumonia and other infections caused by Candida or other species. Micafungin pharmacokinetics in preterm infants appears linear. However, premature infants1000 g on average displayed a shorter half-life (8 hours) and a more rapid rate of clearance (approximately 39 mL/h per kg) compared with published data in older children and adults. All doses of micafungin were well tolerated and no serious drug-related adverse events were observed.: Single doses of micafungin, ranging up to 3.0 mg/kg, appear well tolerated in premature infants weighing1000 g. The drug's elimination half-life and total plasma clearance in preterm infants appear dissimilar to published values for these parameters in older children and adults. The reason(s) for this apparent difference remain to be investigated. |
| Databáze: | OpenAIRE |
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