Evidence map›Paper›PMID 27572399›Full record

ArticleAntimicrobial agents and chemotherapy2016

A Population and Developmental Pharmacokinetic Analysis To Evaluate and Optimize Cefotaxime Dosing Regimen in Neonates and Young Infants.

Stéphanie Leroux, Jean-Michel Roué, Jean-Bernard Gouyon, Valérie Biran, Hao Zheng, Wei Zhao, Evelyne Jacqz-Aigrain

Open access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.1field-weighted citation impact, top 9% 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

17 citing papers in PubMed, 30 citations in OpenAlex.

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  7. Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022
    Review
  8. Population pharmacokinetics of cefotaxime in intensive care patients.European journal of clinical pharmacology · 2022
    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

7 authors at 5 institutions in 2 countries.

Stéphanie LerouxDepartment of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France.
Jean-Michel RouéNeonatal Intensive Care Unit, CHU de Brest, Brest, France.
Jean-Bernard GouyonNeonatal Intensive Care Unit, Centre d'Etudes Périnatales de l'Océan Indien (EA7388), CHU de la Réunion, Réunion, France.
Valérie BiranNeonatal Intensive Care Unit, Hôpital Robert Debré, APHP, Paris, France.
Hao ZhengDepartment of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France.
Wei ZhaoDepartment of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France.
Evelyne Jacqz-AigrainDepartment of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France evelyne.jacqz-aigrain@rdb.aphp.fr.
Assistance Publique – Hôpitaux de Paris · FRHôpital Robert-Debré · FRCentre Hospitalier Régional Universitaire de Brest · FRClinical Investigation Center Plurithematic Tours · FRÉcologie Marine Tropicale des Océans Pacifique et Indien · RE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cefotaxime is one of the most frequently prescribed antibiotics for the treatment of Gram-negative bacterial sepsis in neonates. However, the dosing regimens routinely used in clinical practice vary considerably. The objective of the present study was to conduct a population pharmacokinetic study of cefotaxime in neonates and young infants in order to evaluate and optimize the dosing regimen. An opportunistic sampling strategy combined with population pharmacokinetic analysis using NONMEM software was performed. Cefotaxime concentrations were measured by high-performance liquid chromatography-tandem mass spectrometry. Developmental pharmacokinetics-pharmacodynamics, the microbiological pathogens, and safety aspects were taken into account to optimize the dose. The pharmacokinetic data from 100 neonates (gestational age [GA] range, 23 to 42 weeks) were modeled with an allometric two-compartment model with first-order elimination. The median values for clearance and the volume of distribution at steady state were 0.12 liter/h/kg of body weight and 0.64 liter/kg, respectively. The covariate analysis showed that current weight, GA, and postnatal age (PNA) had significant impacts on cefotaxime pharmacokinetics. Monte Carlo simulations demonstrated that the current dose recommendations underdosed older newborns. A model-based dosing regimen of 50 mg/kg twice a day to four times a day, according to GA and PNA, was established. The associated risk of overdose for the proposed dosing regimen was 0.01%. We determined the population pharmacokinetics of cefotaxime and established a model-based dosing regimen to optimize treatment for neonates and young infants.

Indexed as

Models, StatisticalAnti-Bacterial AgentsBody WeightCefotaximeChromatography, High Pressure LiquidComputer SimulationDrug Administration ScheduleDrug Dosage CalculationsFemaleGestational AgeGram-Negative Bacterial InfectionsHumansInfantInfant, NewbornIntensive Care UnitsMaleAnti-Bacterial AgentsCefotaxime

Identifiers

PMID27572399
PMCPMC5075068
OpenAlexW2517433371

What OpenQuestion holds

Textmetadata
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.