ArticleClinical pharmacology and therapeutics2010
Safety and pharmacokinetics of repeat-dose micafungin in young infants.
Article in Clinical pharmacology and therapeutics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00818584 (A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates), which is not on this map. Cited by 41 papers, 3 of them syntheses that pooled it.
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.
The trial behind it
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.
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Who cites it
41 citing papers in PubMed, 3 syntheses or guidelines pooled it, 130 citations in OpenAlex.
- Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Micafungin in premature and non-premature infants: a systematic review of 9 clinical trials.The Pediatric infectious disease journal · 2014Pooled it
- Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics.The Pediatric infectious disease journal · 2013Guideline
- High-Dose Micafungin in Neonates and Young Infants with Invasive Candidiasis: Results of a Phase 2 Study.Antimicrobial agents and chemotherapy · 2021Trial
- Dietary Supplementation With Medium-Chain Triglycerides Reduces Candida Gastrointestinal Colonization in Preterm Infants.The Pediatric infectious disease journal · 2019Trial
- A Phase 3 Study of Micafungin Versus Amphotericin B Deoxycholate in Infants With Invasive Candidiasis.The Pediatric infectious disease journal · 2018Trial
- Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.British journal of clinical pharmacology · 2018Trial
- Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.Antimicrobial agents and chemotherapy · 2015Trial
- Pharmacokinetics of micafungin in HIV positive patients with confirmed esophageal candidiasis.European journal of drug metabolism and pharmacokinetics · 2012Trial
- Population pharmacokinetics of micafungin in neonates and young infants.Antimicrobial agents and chemotherapy · 2010Trial
- A State of the Art Review on the Recalcitrant Candidiasis as a Clue of Inborn Errors of Immunity in Newborns.Journal of immunology research · 2026Review
- Perspectives on the Use of Echinocandins in the Neonatal Intensive Care Unit.Antibiotics (Basel, Switzerland) · 2024Review
- Usage of Antifungal Agents in Pediatric Patients Versus Adults: Knowledge and Gaps.Mycopathologia · 2024Review
- A Retrospective Analysis of Micafungin Prophylaxis in Children Under 12 Years Undergoing Chemotherapy or Hematopoietic Stem Cell Transplantation.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Antibiotics, Analgesic Sedatives, and Antiseizure Medications Frequently Used in Critically Ill Neonates: A Narrative Review.Children (Basel, Switzerland) · 2024Review
- Treatment with Micafungin in a Preterm Neonate with an InvasivePathogens (Basel, Switzerland) · 2021Article
- Invasive Candidiasis in Infants and Children: Recent Advances in Epidemiology, Diagnosis, and Treatment.Journal of fungi (Basel, Switzerland) · 2019Review
- Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.Journal of clinical pharmacology · 2018Review
- Exposure-Response Analysis of Micafungin in Neonatal Candidiasis: Pooled Analysis of Two Clinical Trials.The Pediatric infectious disease journal · 2018Article
- Clinical Pharmacokinetics and Pharmacodynamics of Micafungin.Clinical pharmacokinetics · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 2 countries.
Funding
Abstract
Given the risk of central nervous system infection, relatively high weight-based echinocandin dosages may be required for the successful treatment of invasive candidiasis and candidemia in young infants. This open-label study assessed the safety and pharmacokinetics (PK) of micafungin in 13 young infants (>48 h and <120 days of life) with suspected candidemia or invasive candidiasis. Infants of body weight > or =1,000 and <1,000 g received 7 and 10 mg/kg/day, respectively, for a minimum of 4-5 days. In the 7-mg/kg/day group, the mean baseline weight and gestational age were 2,101 g and 30 weeks, respectively; in the 10-mg/kg/day group, they were 688 g and 25 weeks, respectively. The median pharmacokinetic values for the 7- and 10-mg/kg/day groups, respectively, were as follows: area under the concentration-time curve from 0 to 24 h (AUC(0-24)), 258.1 and 291.2 microg x h/ml; clearance at steady state adjusted for body weight, 0.45 and 0.57 ml/min/kg; maximum plasma concentration, 23.3 and 24.9 micro g/ml; and volume of distribution at steady state adjusted for body weight, 341.4 and 542.8 ml/kg. No deaths or discontinuations from treatment occurred. These data suggest that micafungin dosages of 7 and 10 mg/kg/day are well tolerated and provide exposure levels that have been shown (in animal models) to be adequate for central nervous system coverage.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.