Evidence map›Paper›PMID 30509939›Full record

ArticleAntimicrobial agents and chemotherapy2019

Population Pharmacokinetics and Dosing Optimization of Amoxicillin in Neonates and Young Infants.

Bo-Hao Tang, Yue-E Wu, Chen Kou, Yu-Jie Qi, Hui Qi, Hai-Yan Xu, Stephanie Leroux, Xin Huang, Yue Zhou, Yi Zheng and 3 more

Open access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
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  3. Article
  4. Observational
  5. Article
  6. Article
  7. CDC Guidelines for the Prevention and Treatment of Anthrax, 2023.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2023
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  11. Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022
    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

13 authors at 4 institutions in 2 countries.

Bo-Hao Tang *Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.
Yue-E Wu *Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.
Chen Kou *Department of Neonatology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.
Yu-Jie QiNeonatal Intensive Care Unit, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.
Hui QiBeijing Key Laboratory of Pediatric Respiratory Infection Diseases, Key Laboratory of Major Diseases in Children, Ministry of Education, National Clinical Research Center for Respiratory Diseases, National Key Discipline of Pediatrics (Capital Medical University), Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.
Hai-Yan XuDepartment of Neonatology, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, China.
Stephanie LerouxNeonatal Intensive Care Unit, CHU de Rennes, Rennes, France.
Xin HuangDepartment of Pharmacy, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, China.
Yue ZhouDepartment of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.
Yi ZhengDepartment of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.
Evelyne Jacqz-AigrainDepartment of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France.
A-Dong ShenBeijing Key Laboratory of Pediatric Respiratory Infection Diseases, Key Laboratory of Major Diseases in Children, Ministry of Education, National Clinical Research Center for Respiratory Diseases, National Key Discipline of Pediatrics (Capital Medical University), Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.
Wei ZhaoDepartment of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China zhao4wei2@hotmail.com.ORCID 0000-0002-1830-338X
Shandong University · CNCapital Medical University · CNAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Rennes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Amoxicillin is widely used to treat bacterial infections in neonates. However, considerable intercenter variability in dosage regimens of antibiotics exists in clinical practice. The pharmacokinetics of amoxicillin has been described in only a few preterm neonates. Thus, we aimed to evaluate the population pharmacokinetics of amoxicillin through a large sample size covering the entire age range of neonates and young infants and to establish evidence-based dosage regimens based on developmental pharmacokinetics-pharmacodynamics. This is a prospective, multicenter, pharmacokinetic study using an opportunistic sampling design. Amoxicillin plasma concentrations were determined using high-performance liquid chromatography. Population pharmacokinetic analysis was performed using NONMEM. A total of 224 pharmacokinetic samples from 187 newborns (postmenstrual age range, 28.4 to 46.3 weeks) were available for analysis. A two-compartment model with first-order elimination was used to describe population pharmacokinetics. Covariate analysis showed that current weight, postnatal age, and gestational age were significant covariates. The final model was further validated for predictive performance in an independent cohort of patients. Monte Carlo simulation demonstrated that for early-onset sepsis, the currently used dosage regimen (25 mg/kg twice daily [BID]) resulted in 99.0% of premature neonates and 87.3% of term neonates achieving the pharmacodynamic target (percent time above MIC), using a MIC breakpoint of 1 mg/liter. For late-onset sepsis, 86.1% of premature neonates treated with 25 mg/kg three times a day (TID) and 79.0% of term neonates receiving 25 mg/kg four times a day (QID) reached the pharmacodynamic target, using a MIC breakpoint of 2 mg/liter. The population pharmacokinetics of amoxicillin was assessed in neonates and young infants. A dosage regimen was established based on developmental pharmacokinetics-pharmacodynamics.

Indexed as

AmoxicillinAnti-Bacterial AgentsBacteriaBacterial InfectionsFemaleHumansInfantInfant, NewbornMaleMicrobial Sensitivity TestsModels, TheoreticalProspective StudiesAmoxicillinAnti-Bacterial Agentsamoxicillindosing optimizationneonatespharmacokinetics

Identifiers

PMID30509939
PMCPMC6355568
OpenAlexW2902468970

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.