Single-dose Pharmacokinetics of Daptomycin in Pediatric Patients 3–24 Months of Age
| Autor: | Richard F. Jacobs, John S. Bradley, David Benziger, Paula M. Bokesch |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Male
Microbiology (medical) medicine.medical_specialty Time Factors MEDLINE medicine.disease_cause Daptomycin Pharmacokinetics Internal medicine polycyclic compounds medicine Humans integumentary system business.industry Infant Bacterial Infections bacterial infections and mycoses medicine.disease Anti-Bacterial Agents Clinical trial Infectious Diseases Multicenter study Staphylococcus aureus Area Under Curve Child Preschool Bacteremia Pediatrics Perinatology and Child Health Skin structure Administration Intravenous Female lipids (amino acids peptides and proteins) business Half-Life medicine.drug |
| Zdroj: | Pediatric Infectious Disease Journal. 33:936-939 |
| ISSN: | 0891-3668 |
| DOI: | 10.1097/inf.0000000000000318 |
| Popis: | Daptomycin is approved for treatment of complicated skin/skin structure infections and Staphylococcus aureus bloodstream infections (bacteremia) in adults. This study was undertaken to determine the pharmacokinetics of daptomycin in pediatric patients 3-24 months of age with proven/suspected bacterial infection.In this phase 1, multicenter, open-label, noncomparative pharmacokinetic and safety study, patients were enrolled in 3 age groups: 3-6, 7-12 and 13-24 months. Intravenous daptomycin (single dose) was infused over 30 minutes at 6 mg/kg in subjects 13-24 months of age and at 4 mg/kg in the younger groups. Blood was collected for analysis of daptomycin concentrations.Twenty-four subjects received daptomycin. Daptomycin exposures (area under the curve0-∞) in children 3-6 and 7-12 months of age receiving 4 mg/kg were similar (215 and 219 μg·h/mL, respectively). Children 13-24 months of age receiving a higher dose, 6 mg/kg, had higher exposures (282 μg·h/mL). Mean maximum plasma concentrations in the age groups were 38.7, 37.1 and 67.0 μg/mL, respectively. Daptomycin exposures based on mg/kg dosing were lower than previously reported for older children and adults, likely because of increased clearance and volume of distribution and decreased apparent elimination half-life. Single-dose daptomycin 4 and 6 mg/kg was well tolerated and was not associated with clinical or laboratory adverse events.To match known clinically and microbiologically effective exposures in adults, infants require higher mg/kg daptomycin doses. Daptomycin safety and efficacy have not been established in pediatric patients. Pediatric clinical trials are ongoing. |
| Databáze: | OpenAIRE |
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