Evidence map›Paper›PMID 22569355›Full record

Trial reportTherapeutic drug monitoring2012

Population pharmacokinetics of piperacillin using scavenged samples from preterm infants.

Michael Cohen-Wolkowiez, Daniel K Benjamin, Ashley Ross, Laura P James, Janice E Sullivan, Michele C Walsh, Arlene Zadell, Nancy Newman, Nicole R White, Angela D M Kashuba and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Therapeutic drug monitoring, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
5.1field-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.

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

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
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  18. Review
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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.

Michael Cohen-WolkowiezDepartment of Pediatrics, Duke University, Durham, North Carolina 27715, USA. michael.cohenwolkowiez@duke.edu
Daniel K Benjamin
Ashley Ross
Laura P James
Janice E Sullivan
Michele C Walsh
Arlene Zadell
Nancy Newman
Nicole R White
Angela D M Kashuba
Daniele Ouellet
University Hospitals of Cleveland · USDuke University · USJohns Hopkins University Center for AIDS ResearchUniversity of Arkansas for Medical Sciences · USClinical Research Institute · USUniversity of Louisville · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR029884 · NCRR · UNIV OF ARKANSAS FOR MED SCIS · PI LOWERY, CURTIS L · 2009 to 2011
$11.4M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01HD057956 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2012
$2.8M
Preventing HIV Infection in Women: Targeting Antiretrovirals to Mucosal TissuesU01AI095031 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KASHUBA, ANGELA D · 2011 to 2013
$2.4M
North Carolina Collaborative PPRU NetworkU10HD045962 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2004 to 2009
$2.1M
Center for Pediatric Clinical Pharmacology ResearchU10HD045934 · NICHD · UNIVERSITY OF LOUISVILLE · PI SULLIVAN, JANICE E · 2004 to 2009
$2.0M
Identification of new mechanistic biomarkers of adverse responses to acetaminopheR01DK081406 · NIDDK · ARKANSAS CHILDREN'S HOSPITAL RES INST · PI JAMES, LAURA P · 2009 to 2013
$1.9M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01FD003519 · FDA · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2011
$1.6M
Metabolism and Toxicity of Acetaminophen in Preterm InfantsR01HD060543 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2010 to 2014
$1.5M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
HIF-1alpha and VEGF in Acetaminophen Toxicity and RepairR01DK075936 · NIDDK · UNIV OF ARKANSAS FOR MED SCIS · PI JAMES, LAURA P · 2007 to 2011
$1.3M
Pharmacokinetics and Pharmacodynamics of Antibiotics in Premature InfantsK23HD064814 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2010 to 2013
$474k
FDA HHS R01 FD003519NCRR NIH HHS UL1 RR029884NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI095031NICHD NIH HHS HHSN267200700051CNICHD NIH HHS K23 HD064814NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD057956NICHD NIH HHS R01 HD060543NICHD NIH HHS U10 HD045934NICHD NIH HHS U10 HD045962NIDDK NIH HHS R01 DK075936NIDDK NIH HHS R01 DK081406
6 · The paper itself

Abstract

objectivesPiperacillin is often used in preterm infants for intra-abdominal infections; however, dosing has been derived from small single-center studies excluding extremely preterm infants at a highest risk for these infections. We evaluated the population pharmacokinetics (PK) of piperacillin using targeted sparse sampling and scavenged samples obtained from preterm infants ≤ 32 weeks of gestational age at birth and <120 postnatal days. MATERIALS AND

methodsA 5-center study was performed. A population PK model using nonlinear mixed effect modeling was developed. Covariate effects were evaluated based on the estimated precision and clinical significance.

resultsFifty-six preterm infants were evaluated and had a median (range) gestational age at birth of 25 (22-32) weeks, a postnatal age of 17 (1-77) days, a postmenstrual age of 29 (23-40) weeks, and a weight of 867 (400-2580) g. The final PK data set contained 211 samples; 202/211 (96%) were scavenged from the discarded clinical specimens. Piperacillin population PK was best described by a 1-compartment model. The population mean clearance (CL) was derived by the equation CL (L/h) = 0.479 × (weight)(0.75) × 0.5/serum creatinine and using a volume of distribution (V) (L) of 2.91 × (weight). The relative standard errors around parameter estimates ranged from 13.7% to 32.2%. A trend toward increased CL was observed with increasing gestational age at birth; infants with serum creatinine ≥ 1.2 mg/dL had a 60% reduction in piperacillin CL. The majority (>70%) of infants did not meet predefined pharmacodynamic efficacy targets.

conclusionsScavenged PK sampling is a minimal-risk approach that can provide meaningful information related to the development of PK models but not dosing recommendations for piperacillin. The utility of scavenged sampling in providing definitive dosing recommendations may be drug dependent and needs to be further explored.

Indexed as

Anti-Bacterial AgentsBlood Specimen CollectionComputer SimulationFemaleGestational AgeHumansInfant, NewbornInfant, PrematureMaleModels, ChemicalPiperacillinProspective StudiesAnti-Bacterial AgentsPiperacillin

Identifiers

PMID22569355
PMCPMC3354042
OpenAlexW1991930487

What OpenQuestion holds

Textmetadata
LicenceTDM
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.