Evidence map›Paper›PMID 24346595›Full record

Trial reportThe Pediatric infectious disease journal2014

Population pharmacokinetics of intravenous acyclovir in preterm and term infants.

Mario R Sampson, Barry T Bloom, Robert W Lenfestey, Barrie Harper, Angela D Kashuba, Ravinder Anand, Daniel K Benjamin, Edmund Capparelli, Michael Cohen-Wolkowiez, P Brian Smith and 1 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in The Pediatric infectious disease journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
3.1field-weighted citation impact, top 8% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Creativity in Pediatric Clinical Pharmacology: Study Design and Oral Dosage Forms.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Association between neonatal intensive care unit medication safety practices, adverse events, and death.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  9. Article
  10. Neonatal Therapeutics: Considerations for Dosing.American journal of perinatology · 2019
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Neonatal Herpes Simplex Viral Infections and Acyclovir: An Update.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG
    Review
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

11 authors at 6 institutions in 1 country.

Mario R SampsonFrom the *Duke Clinical Research Institute, Durham; †University of North Carolina, Eshelman School of Pharmacy, Chapel Hill, NC; ‡Wichita Medical Research and Education Foundation, Wichita, KS; §EMMES Corporation, Rockville, MD; and ¶University of California-San Diego, Schools of Medicine and Pharmacy, La Jolla, CA.
Barry T Bloom
Robert W Lenfestey
Barrie Harper
Angela D Kashuba
Ravinder Anand
Daniel K Benjamin
Edmund Capparelli
Michael Cohen-Wolkowiez
P Brian Smith
Best Pharmaceuticals for Children Act–Pediatric Trials Network
Clinical Research Institute · USDuke University · USEmmes (United States) · USUniversity of California, San Diego · USUniversity of North Carolina at Chapel Hill · USWichita Medical Research and Education Foundation · US

Funding

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
TRAINING & OUTREACH COREU54HD071600 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CAPPARELLI, EDMUND VINCENT · 2011 to 2015
$3.6M
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
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
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
ASPE HHS 1R18AE000028-01FDA HHS 1U01FD004858-01FDA HHS U01 FD004858NICHD NIH HHS 1K23HD060040-01NICHD NIH HHS 1K23HD064814NICHD NIH HHS 1K24HD058735-05NICHD NIH HHS 1R01HD057956-05NICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000001GNICHD NIH HHS HHSN275201000001ZNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD060040NICHD NIH HHS K23 HD064814NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD057956NICHD NIH HHS U54 HD071600NICHD NIH HHS U54 HD071600-01NIDDK NIH HHS HHSN267200700051CNIGMS NIH HHS T32 GM086330NIGMS NIH HHS T32GM086330
6 · The paper itself

Abstract

backgroundAcyclovir is used to treat herpes infections in preterm and term infants; however, the influence of maturation on drug disposition and dosing requirements is poorly characterized in this population.

methodsWe administered intravenous acyclovir to preterm and term infants <31 days postnatal age and collected plasma samples. We performed a population pharmacokinetic analysis. The primary pharmacodynamic target was acyclovir concentration ≥3 mg/L for ≥50% of the dosing interval. The final model was simulated using infant data from a clinical database.

resultsThe analysis included 28 infants (median 30 weeks gestation). Acyclovir pharmacokinetics was described by a 1-compartment model: clearance (L/h/kg) = 0.305 × [postmenstrual age (PMA)/31.3 weeks]. This equation predicts a 4.5-fold increase in clearance from 25 to 41 weeks PMA. With proposed dosing, the pharmacodynamic target was achieved in 91% of infants: 20 mg/kg every 12 hours in infants <30 weeks PMA; 20 mg/kg every 8 hours in infants 30 to <36 weeks PMA and 20 mg/kg every 6 hours in infants 36-41 weeks PMA.

conclusionsAcyclovir clearance increased with infant maturation. A dosing strategy based on PMA accounted for developmental changes in acyclovir disposition to achieve the surrogate pharmacodynamic target in many infants.

Indexed as

AcyclovirAdministration, IntravenousAntiviral AgentsBayes TheoremCluster AnalysisFemaleHumansInfantInfant, NewbornInfant, PrematureMaleAcyclovirAntiviral Agents

Identifiers

PMID24346595
PMCPMC3904301
OpenAlexW2141205716

What OpenQuestion holds

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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.