ArticleThe Pediatric infectious disease journal2013
Safety and pharmacokinetic profiles of repeated-dose micafungin in children and adolescents treated for invasive candidiasis.
Article in The Pediatric infectious disease journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 21 citations in OpenAlex.
- Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.Antimicrobial agents and chemotherapy · 2015Trial
- Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.Paediatric drugs · 2020Review
- Advances in the Treatment of Mycoses in Pediatric Patients.Journal of fungi (Basel, Switzerland) · 2018Review
- Clinical Pharmacokinetics and Pharmacodynamics of Micafungin.Clinical pharmacokinetics · 2018Review
- Advances in pediatric pharmacology, therapeutics, and toxicology.Advances in pediatrics · 2014Review
- Pharmacokinetics and pharmacodynamics of antifungals in children: clinical implications.Drugs · 2014Review
Corrections and comments
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Authors and funding
7 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundMicafungin is an echinocandin with proven efficacy against a broad range of fungal infections, including those caused by Candida spp.
objectiveTo evaluate the safety and pharmacokinetics of once-daily 3 mg/kg and 4.5 mg/kg micafungin in children with proven, probable or suspected invasive candidiasis.
methodsMicafungin safety and pharmacokinetics were assessed in 2 phase I, open-label, repeat-dose trials. In Study 2101, children aged 2-16 years were grouped by weight to receive 3 mg/kg (≥25 kg) or 4.5 mg/kg (<25 kg) intravenous micafungin for 10-14 days. In Study 2102, children aged 4 months to <2 years received 4.5 mg/kg micafungin. Study protocols were otherwise identical.
resultsSafety was analyzed in 78 and 9 children in Studies 2101 and 2102, respectively. Although adverse events (AEs) were experienced by most children (2101: n=62; 2102: n=9), micafungin-related AEs were less common (2101: n=28; 2102: n=1), and the number of patients discontinuing due to AEs was low (2101: n=4; 2102: n=1). The most common micafungin-related AEs were infusion-associated symptoms, pyrexia and hypomagnesemia (Study 2101), and liver function abnormalities (Study 2102). The micafungin pharmacokinetic profile was similar to that seen in other studies conducted in children, but different than that observed in adults.
conclusionsIn this small cohort of children, once-daily doses of 3 mg/kg and 4.5 mg/kg micafungin were well tolerated. Pharmacokinetic data will be combined in a population pharmacokinetic analysis to support US dosing recommendations in children.
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