Evidence map›Paper›PMID 28410277›Full record

ArticleThe Pediatric infectious disease journal2017

Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants.

Sara Salerno, Christoph P Hornik, Michael Cohen-Wolkowiez, P Brian Smith, Lawrence C Ku, Matthew S Kelly, Reese Clark, Daniel Gonzalez, Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee

Open access · greenAbstract read
In one paragraph

Article in The Pediatric infectious disease journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
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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

9 authors at 4 institutions in 1 country.

Sara SalernoFrom the *Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; †Department of Pediatrics, and ‡Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; and §Pediatrix Medical Group, Inc., Sunrise, Florida.
Christoph P Hornik
Michael Cohen-Wolkowiez
P Brian Smith
Lawrence C Ku
Matthew S Kelly
Reese Clark
Daniel Gonzalez
Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee
Sunrise Medical (United States) · USUniversity of North Carolina at Chapel Hill · USClinical Research Institute · USDuke Medical Center · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
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
Center for Molecular &Cellular Studies of Ped DiseaseK12HD043494 · NICHD · DUKE UNIVERSITY · PI REED, ANN M. · 2003 to 2017
$5.2M
Duke Research Training Program for PediatriciansT32HD043029 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2002 to 2017
$3.7M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Use of Physiologically-Based PK/PD Models to Streamline Drug ApprovalsK23HD083465 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GONZALEZ, DANIEL · 2015 to 2019
$727k
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
North Carolina Translational & Clinical Sciences Institute (NC TraCS)TL1TR001110 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$489k
PATIENT SAFETY RESEARCH DURING NEONATAL CARE (R21)R21HD080606 · NICHD · DUKE UNIVERSITY · PI SMITH, PHILLIP BRIAN · 2015 to 2016
$457k
FDA HHS R18 FD005292FDA HHS U01 FD004858NCATS NIH HHS TL1 TR001110NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1 TR002489NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K12 HD043494NICHD NIH HHS K23 HD083465NICHD NIH HHS R01 HD076676NICHD NIH HHS R21 HD080606NICHD NIH HHS T32 HD043029NIGMS NIH HHS T32 GM086330
6 · The paper itself

Abstract

backgroundPiperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health record (EHR) data can be used to evaluate drug safety in infants, but measures of drug exposure are lacking.

methodsTo relate simulated piperacillin exposure with adverse events (AEs) in infants using EHR data, we identified infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012. Using a previously published population pharmacokinetic model in the target population, we simulated piperacillin steady state area under the concentration versus time curve from zero to τ (AUCss,0-τ) and steady state maximal drug concentration (Cmaxss). Next, we used multivariable logistic regression to evaluate the association between simulated AUCss,0-τ and Cmaxss with clinical AEs (seizure and rash) and laboratory AEs controlling for gestational age. The odds ratios (95% confidence intervals) comparing the third versus the first tertiles for AUCss,0-τ and Cmaxss were reported.

resultsWe identified 746 infants with a median (interquartile range) gestational age of 30 weeks (26-33) and postnatal age of 11 days (6-25). The median (interquartile range) piperacillin dose was 225 mg/kg/d (176-300). No significant associations were found between simulated piperacillin exposure (AUCss,0-τ and Cmaxss) and clinical and laboratory AEs.

conclusionsWe found no associations between predicted piperacillin exposures and the occurrence of AEs. This study confirms the feasibility of using population pharmacokinetics and EHR to relate drug exposure with safety.

Indexed as

Anti-Bacterial AgentsArea Under CurveCross InfectionElectronic Health RecordsFemaleHumansInfantInfant, NewbornMalePenicillanic AcidPiperacillinPiperacillin, Tazobactam Drug CombinationRetrospective StudiesAnti-Bacterial AgentsPenicillanic AcidPiperacillinPiperacillin, Tazobactam Drug Combination

Identifiers

PMID28410277
PMCPMC5555808
OpenAlexW2605775369

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.