Evidence map›Paper›PMID 25421470›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.

William W Hope, Atsunori Kaibara, Michael Roy, Antonio Arrieta, Nkechi Azie, Laura L Kovanda, Daniel K Benjamin

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Postantifungal Effect of Antifungal Drugs againstJournal of fungi (Basel, Switzerland) · 2022
    Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Pediatric Invasive Aspergillosis.Journal of fungi (Basel, Switzerland) · 2016
    Review
  19. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

William W HopeDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom william.hope@liverpool.ac.uk.
Atsunori KaibaraAstellas Pharma, Northbrook, Illinois, USA.
Michael RoyAstellas Pharma, Northbrook, Illinois, USA.
Antonio ArrietaChildren's Hospital of Orange County, Division of Infectious Disease, Orange, California, USA.
Nkechi AzieAstellas Pharma, Northbrook, Illinois, USA.
Laura L KovandaAstellas Pharma, Northbrook, Illinois, USA.
Daniel K BenjaminDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Astellas Pharma (United States) · USChildren's Hospital of Orange County · USDuke University · USUniversity of Liverpool · GB

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01HD057956 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2012
$2.8M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1TR001117NICHD NIH HHS 1K24HD058735-05NICHD NIH HHS 1R01HD057956-05NICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD057956
6 · The paper itself

Abstract

The aim of this analysis was to identify therapeutic micafungin regimens for children that produce the same micafungin exposures known to be effective for the prevention and treatment of Candida infections in adults. Pediatric pharmacokinetic data from 229 patients between the ages of 4 months and <17 years were obtained from four phase I and two phase III clinical trials. Population pharmacokinetic models were used to simulate the proportion of children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml. Simulated pediatric dosages of 0.5 to 5 mg/kg of body weight/day were explored. A two-compartment model was used that incorporated body weight as a predefined covariate for allometric scaling of the pharmacokinetic parameters. During construction of the model, aspartate aminotransferase and total bilirubin were also identified as covariates that had a significant effect on micafungin clearance. A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis. Cutoffs of 40 or 50 kg for weight-based dosing resulted in heavier children being appropriately dosed. Thus, dose regimens of 1, 2, and 3 mg/kg/day micafungin are appropriate for the prevention of invasive candidiasis, the treatment of invasive candidiasis, and the treatment of esophageal candidiasis, respectively, in children aged 4 months to <17 years.

Indexed as

AdolescentAntifungal AgentsCandidiasisCandidiasis, InvasiveChildChild, PreschoolEchinocandinsFemaleHumansInfantLipopeptidesMaleMicafunginAntifungal AgentsEchinocandinsLipopeptidesMicafungin

Identifiers

PMID25421470
PMCPMC4335897
OpenAlexW2156187027

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.