Evidence map›Paper›PMID 31785929›Full record

ArticleJournal of pharmaceutical and biomedical analysis2020

Development and validation of a volumetric absorptive microsampling- liquid chromatography mass spectrometry method for the analysis of cefepime in human whole blood: Application to pediatric pharmacokinetic study.

Ganesh S Moorthy, Christina Vedar, Nicole R Zane, Kevin J Downes, Janice L Prodell, Mary Ann DiLiberto, Athena F Zuppa

Open access · greenAbstract readValidation Study
In one paragraph

Article in Journal of pharmaceutical and biomedical analysis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

16 citing papers in PubMed, 31 citations in OpenAlex.

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  12. Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022
    Review
  13. Review
  14. Review on Characterization, Properties, and Analytical Methods of Cefepime.International journal of analytical chemistry · 2022
    Review
  15. Article
  16. 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

7 authors at 2 institutions in 1 country.

Ganesh S MoorthyCenter for Clinical Pharmacology, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States; Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States. Electronic address: moorthyg@email.chop.edu.
Christina VedarCenter for Clinical Pharmacology, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States.
Nicole R ZaneCenter for Clinical Pharmacology, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States.
Kevin J DownesCenter for Clinical Pharmacology, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States; Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, United States.
Janice L ProdellCenter for Clinical Pharmacology, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States; Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States.
Mary Ann DiLibertoCenter for Clinical Pharmacology, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States; Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States.
Athena F ZuppaCenter for Clinical Pharmacology, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States; Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, 19104, United States.
Children's Hospital of Philadelphia · USUniversity of Pennsylvania · US

Funding

Optimizing Vancomycin Therapy in ChildrenK23HD091365 · NICHD · CHILDREN'S HOSP OF PHILADELPHIA · PI DOWNES, KEVIN JAMES · 2018 to 2022
$747k
A Model Based Approach to Individualizing Antimicrobial Dosing in Pediatric SepsisK99HD096123 · NICHD · CHILDREN'S HOSP OF PHILADELPHIA · PI ZANE, NICOLE R · 2018 to 2019
$221k
NICHD NIH HHS K23 HD091365NICHD NIH HHS K99 HD096123
6 · The paper itself

Abstract

Cefepime is a fourth-generation cephalosporin antibiotic with an extended spectrum of activity against many Gram-positive and Gram-negative bacteria. There is a growing need to develop sensitive, small volume assays, along with less invasive sample collection to facilitate pediatric pharmacokinetic clinical trials and therapeutic drug monitoring. The volumetric absorptive microsampling (VAMS™) approach provides an accurate and precise collection of a fixed volume of blood (10 μL), reducing or eliminating the volumetric blood hematocrit assay-bias associated with the dried blood spotting technique. We developed a high-performance liquid chromatographic method with tandem mass spectrometry detection for quantification of cefepime. Sample extraction from VAMS™ devices, followed by reversed-phase chromatographic separation and selective detection using tandem mass spectrometry with a 4 min runtime per sample was employed. Standard curves were linear between 0.1-100 μg/mL for cefepime. Intra- and inter-day accuracies were within 95.4-113% and precision (CV) was < 15 % based on a 3-day validation study. Recoveries ranged from 40.8 to 62.1% and the matrix effect was within 89.5-96.7% for cefepime. Cefepime was stable in human whole blood under assay conditions (3 h at room temperature, 24 h in autosampler post-extraction). Cefepime was also stable for at least 1 week (7 days) at 4 °C, 1 month (39 days) at -20 °C and 3 months (91 days) at -78 °C as dried microsamples. This assay provides an efficient quantitation of cefepime and was successfully implemented for the analysis of whole blood microsamples in a pediatric clinical trial.

Indexed as

Anti-Bacterial AgentsCefepimeChildChromatography, High Pressure LiquidChromatography, Reverse-PhaseDrug MonitoringDrug StabilityDrug StorageHumansTandem Mass SpectrometryTemperatureAnti-Bacterial AgentsCefepimeCefepimeHuman whole bloodLiquid chromatographyMass spectrometryVolumetric absorptive microsampling (VAMS™)

Identifiers

PMID31785929
PMCPMC6943186
OpenAlexW2990688927

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.