Evidence map›Paper›PMID 23230059›Full record

ArticleThe Journal of infectious diseases2013

Oseltamivir pharmacokinetics, dosing, and resistance among children aged <2 years with influenza.

David W Kimberlin, Edward P Acosta, Mark N Prichard, Pablo J Sánchez, Krow Ampofo, David Lang, Negar Ashouri, John A Vanchiere, Mark J Abzug, Nazha Abughali and 13 more

Registry-linked trialAbstract read
In one paragraph

Article in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00391768 (A Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT00391768 phase1 / phase2completednot on this map

A Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) for the Treatment of Children Less Than 24 Months of Age With Confirmed Influenza Infection (CASG 114)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2007 to 2010Enrolled87ConditionsInfluenzaArmsoseltamivir (Tamiflu®)
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  5. Article
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  11. Article
  12. Article
  13. Antiviral Treatments.Clinics in chest medicine · 2017
    Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Seasonal Human Influenza: Treatment Options.Current treatment options in infectious diseases · 2014
    Review
  19. Review
  20. Guidance on the use of antiviral drugs for influenza in acute care facilities in Canada, 2014-2015.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 16 institutions in 1 country.

David W KimberlinDepartment of Pediatrics, University of Alabama at Birmingham, AL 35233, USA. dkimberlin@peds.uab.edu
Edward P Acosta
Mark N Prichard
Pablo J Sánchez
Krow Ampofo
David Lang
Negar Ashouri
John A Vanchiere
Mark J Abzug
Nazha Abughali
Mary T Caserta
Janet A Englund
Sunil K Sood
Michael G Spigarelli
John S Bradley
Judy Lew
Marian G Michaels
Wen Wan
Gretchen Cloud
Penelope Jester
Fred D Lakeman
Richard J Whitley
National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
University of Alabama at Birmingham · USUniversity of Florida · USCase Western Reserve University · USChildren's Hospital of Orange County · USCincinnati Children's Hospital Medical Center · USCohen Children's Medical Center · USLouisiana State University Health Sciences Center Shreveport · USMiller Children's & Women's Hospital · USRady Children's Hospital-San Diego · USSeattle Children's Hospital · USThe University of Texas Southwestern Medical Center · USUniversity of Colorado Denver · USUniversity of Pittsburgh · USUniversity of Rochester · USUniversity of Utah · USVirginia Commonwealth University · US

Funding

UNIVERSITY OF ROCHESTER'S RESEARCH ASSOCIATE ORGANIZATIONUL1RR024160 · NCRR · UNIVERSITY OF ROCHESTER · PI PEARSON, THOMAS ARTHUR · 2006 to 2011
$38.7M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
CLINICAL STUDIES OF THERAPIES FOR VIRUS INFECTIONS-266965306N01AI065306 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 1996 to 2003
$250k
THERAPIES FOR SEVERE HERPES VIRUS INFECTIONN01AI015113 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WHITIEY, RICHARD D · 1991 to 1995
–
TRIAL ON ANTIVIRALS FOR SEVERE HERPESVIRUS INFECTIONSN01AI062554 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WHITLEY, RICHARD J · 1986 to 1990
–
CLINICAL TRIALS FOR ANTIVIRAL THERAPIES-266030025-266030025N01AI030025 · NIAID · UNIVERSITY OF ALABAMA BIRMINGH · PI WHITLEY, RICHARD R · 2003 to 2006
–
NCATS NIH HHS UL1 TR000454NCRR NIH HHS UL1 RR024160NCRR NIH HHS UL1 RR025008NIAID NIH HHS N01 AI030025NIAID NIH HHS N01-AI-15113NIAID NIH HHS N01-AI-62554NIAID NIH HHS N01-AI -65306
6 · The paper itself

Abstract

backgroundChildren <2 years of age are at high risk of influenza-related mortality and morbidity. However, the appropriate dose of oseltamivir for children <2 years of age is unknown.

methodsThe National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group evaluated oseltamivir in infants aged <2 years in an age-de-escalation, adaptive design with a targeted systemic exposure.

resultsFrom 2006 to 2010, 87 subjects enrolled. An oseltamivir dose of 3.0 mg/kg produced drug exposures within the target range in subjects 0-8 months of age, although there was a greater degree of variability in infants <3 months of age. In subjects 9-11 months of age, a dose of 3.5 mg/kg produced drug exposures within the target range. Six of 10 subjects aged 12-23 months receiving the Food and Drug Administration-approved unit dose for this age group (ie, 30 mg) had oseltamivir carboxylate exposures below the target range. Virus from 3 subjects developed oseltamivir resistance during antiviral treatment.

conclusionsThe appropriate twice-daily oral oseltamivir dose for infants ≤8 months of age is 3.0 mg/kg, while the dose for infants 9-11 months old is 3.5 mg/kg.

Indexed as

Drug Resistance, ViralAdministration, OralFemaleHumansInfantInfant, NewbornInfluenza, HumanMaleOrthomyxoviridaeOseltamivirOseltamivir

Identifiers

PMID23230059
PMCPMC3563309
OpenAlexW2150092940

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.