Evidence map›Paper›PMID 21412233›Full record

ArticleClinical pharmacology and therapeutics2011

Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates.

M Cohen-Wolkowiez, D K Benjamin, L Piper, I M Cheifetz, C Moran, P Liu, J Aram, A D M Kashuba, E Capparelli, T J Walsh and 2 more

Abstract readComparative Study
In one paragraph

Article in Clinical pharmacology and therapeutics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.9field-weighted citation impact, top 4% 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

23 citing papers in PubMed, 75 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Observational
  8. Review
  9. Review
  10. Advances in the Treatment of Mycoses in Pediatric Patients.Journal of fungi (Basel, Switzerland) · 2018
    Review
  11. Review
  12. Article
  13. Advances in the treatment of invasive neonatal candidiasis.Expert opinion on pharmacotherapy · 2015
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Invasive fungal infections in infants-focus on anidulafungin.Clinical medicine insights. Pediatrics · 2013
    Article
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

12 authors at 8 institutions in 2 countries.

M Cohen-WolkowiezDepartment of Pediatrics, Duke University, Durham, North Carolina, USA. michael.cohenwolkowiez@duke.edu
D K Benjamin
L Piper
I M Cheifetz
C Moran
P Liu
J Aram
A D M Kashuba
E Capparelli
T J Walsh
W W Hope
P B Smith
Duke University · USPfizer (United States) · USClinical Research Institute · USCornell University · USDuke University Hospital · USUniversity of California, San Diego · USUniversity of Manchester · GBUniversity of North Carolina at Chapel Hill · US

Funding

Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01HD057956 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2012
$2.8M
North Carolina Collaborative PPRU NetworkU10HD045962 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2004 to 2009
$2.1M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01FD003519 · FDA · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2011
$1.6M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Pharmacokinetics and Pharmacodynamics of Antibiotics in Premature InfantsK23HD064814 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2010 to 2013
$474k
PHARMACOKINETICS OF ANTIMICROBIAL AGENTS IN HIGH RISK INFANTSK23HD060040 · NICHD · DUKE UNIVERSITY · PI SMITH, PHILLIP BRIAN · 2009 to 2012
$445k
Preventing HIV Infection in Women: Targeting Antiretrovirals to Mucosal TissuesR34AI087065 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KASHUBA, ANGELA D · 2010 to 2010
$111k
FDA HHS 1R01FD003519-01FDA HHS R01 FD003519NIAID NIH HHS P30AI37260NIAID NIH HHS R34 AI087065NIAID NIH HHS R34AI087065NICHD NIH HHS 1K23HD060040-01NICHD NIH HHS 1K23HD064814-01NICHD NIH HHS 1K24HD058735-01NICHD NIH HHS 1R01HD057956-02NICHD NIH HHS 1U10-HD45962-06NICHD NIH HHS HHSN267200700051CNICHD NIH HHS K23 HD060040NICHD NIH HHS K23 HD064814NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD057956NICHD NIH HHS U10 HD045962
6 · The paper itself

Abstract

Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to determine the PK and safety of anidulafungin in infants and neonates at risk for invasive candidiasis. Intravenous anidulafungin (1.5 mg/kg/day maintenance dose) was administered to 15 infants and neonates over 3 to 5 days. Plasma samples were collected after the first dose and again after the third to fifth doses. The pharmacokinetic parameters of the drug were determined by noncompartmental analysis. Safety was assessed using National Cancer Institute common toxicity criteria. The study showed that drug exposure levels were similar between neonates and infants; the median areas under the concentration-time curve (range) was 75 (30-109) µg·h/ml and 98 (55-278) µg·h/ml (P = 0.12) for neonates and infants, respectively. No drug-related serious adverse events were observed. The study results indicate that neonates and infants receiving 1.5 mg/kg/day have anidulafungin exposure levels similar to those in children receiving similar weight-based dosing and in adult patients receiving 100 mg/day.

Indexed as

Age FactorsAnidulafunginAntifungal AgentsArea Under CurveCandidaCandidiasis, InvasiveDose-Response Relationship, DrugEchinocandinsFemaleHumansInfantInfant, NewbornMaleAnidulafunginAntifungal AgentsEchinocandins

Identifiers

PMID21412233
PMCPMC3124385
OpenAlexW2119746598

What OpenQuestion holds

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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.