Evidence map›Paper›PMID 29271816›Full record

ArticleTherapeutic drug monitoring2018

Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.

Jennifer Le, Brenda Poindexter, Janice E Sullivan, Matthew Laughon, Paula Delmore, Martha Blackford, Ram Yogev, Laura P James, Chiara Melloni, Barrie Harper and 4 more

2 registry-linked trialsAbstract readComparative StudyMulticenter Study
In one paragraph

Article in Therapeutic drug monitoring, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 29% 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.

NCT01431326 completednot on this map

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

TypeobservationalSponsorDaniel BenjaminRan2011 to 2019Enrolled3,520ConditionsAdenovirus, Anesthesia, Anxiety, AnxiolysisArmsThe POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
NCT04278404 recruitingnot on this mapstarted 2020, after this paper: background citation

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

TypeobservationalSponsorDuke UniversityRan2020 to 2026Enrolled5,000ConditionsCoronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, HypertensionArmsThe POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. 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
  3. Review
  4. Article
  5. Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022
    Review
  6. Article
  7. 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

14 authors at 11 institutions in 1 country.

Jennifer LeSkaggs School of Pharmacy, University of California, San Diego, San Diego, California.
Brenda PoindexterIndiana University School of Medicine, Indianapolis, Indiana.
Janice E SullivanKosair Charities Pediatric Clinical Research Unit, Norton Children's Hospital, University of Louisville, Louisville, Kentucky.
Matthew LaughonUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Paula DelmoreWesley Medical Center, Wichita, Kansas.
Martha BlackfordAkron Children's Hospital, Akron, Ohio.
Ram YogevAnn and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.
Laura P JamesUniversity of Arkansas for Medical Sciences, Arkansas Children's Hospital at Little Rock, Little Rock, Arkansas.
Chiara MelloniDuke University Medical Center.
Barrie HarperDuke Clinical Research Institute, Durham, North Carolina.
Jeff MitchellThe EMMES Corporation, Rockville, Maryland.
Daniel K BenjaminDuke University Medical Center.
Felix Boakye-AgyemanDuke University Medical Center.
Michael Cohen-WolkowiezDuke University Medical Center.
Clinical Research Institute · USAkron Children's Hospital · USDuke Medical Center · USEmmes (United States) · USIndiana University School of MedicineKosair Children's Hospital · USLurie Children's Hospital · USUniversity of Arkansas for Medical Sciences · USUniversity of Montana · USUniversity of North Carolina at Chapel Hill · USWesley Medical Center · US

Funding

Project-005U2COD023375 · OD · DUKE UNIVERSITY · PI Phillip Brian Smith · 2016 to 2026
$215.9M
COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., BERNARD, GORDON RAPHAEL · 2016 to 2022
$177.0M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Safety and Dose Optimization of High-Dose Anakinra in Kawasaki DiseaseU54HD090259 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CAPPARELLI, EDMUND VINCENT, NIZET, VICTOR · 2016 to 2018
$2.2M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Safety and Dose Optimization of High-Dose Anakinra in Kawasaki DiseaseP50HD090259 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TREMOULET, ADRIANA H · 2019 to 2020
$1.4M
Pharmacokinetic-Pharmacodynamics of Antimicrobials in Resistant InfectionsK23AI089978 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LE, JENNIFER · 2010 to 2014
$641k
NCATS NIH HHS U24 TR001608NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNIAID NIH HHS K23 AI089978NICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K24 HD058735NICHD NIH HHS P50 HD090259NICHD NIH HHS R01 HD076676NICHD NIH HHS U54 HD090259NIDDK NIH HHS HHSN267200700051CNIH HHS U2C OD023375
6 · The paper itself

Abstract

backgroundDried blood spot (DBS) is a practical sampling strategy for pharmacokinetic studies in neonates. The utility of DBS to determine the population pharmacokinetics (pop-PK) of ampicillin, as well as accuracy versus plasma samples, was evaluated.

methodsAn open-label, multicenter, opportunistic, prospective study was conducted in neonates. Ampicillin concentrations from plasma and DBS (CONCPlasma and CONCDBS) were measured by liquid chromatographic tandem mass spectrometry and analyzed using pop-PK and statistical (including transformation) approaches.

resultsA total of 29 paired plasma and DBS samples from 18 neonates were analyzed. The median (range) gestational age and postnatal age were 37 (27-41) weeks and 8 (1-26) days, respectively. The geometric mean of CONCDBS to CONCPlasma ratio was 0.56. Correlation analysis demonstrated strong association between CONCPlasma and CONCDBS (r = 0.902, analysis of variance P < 0.001). Using linear regression transformation, the estimated CONCPlasma (eCONCPlasma) was derived using (CONCDBS - 3.223)/0.51. The median bias and geometric mean ratio improved to -11% and 0.88 (Wilcoxon signed-rank test, P < 0.001), respectively, when comparing eCONCPlasma to CONCPlasma. Furthermore, using pop-PK modeling, the median bias (interquartile range) for clearance and individual predicted concentrations improved to 8% (-11 to 50) and -8% (-34 to 11), respectively, when eCONCPlasma was used.

conclusionsAfter transformation, DBS sampling accurately predicted ampicillin exposure in neonates.

Indexed as

AmpicillinChromatography, LiquidDried Blood Spot TestingFemaleHumansInfant, NewbornMaleModels, BiologicalProspective StudiesTandem Mass SpectrometryAmpicillin

Identifiers

PMID29271816
PMCPMC5764797
OpenAlexW2779439162

What OpenQuestion holds

Textmetadata
LicenceTDM
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.