Evidence map›Paper›PMID 25155587›Full record

Trial reportAntimicrobial agents and chemotherapy2014

Population pharmacokinetics of ciprofloxacin in neonates and young infants less than three months of age.

Wei Zhao, Helen Hill, Chantal Le Guellec, Tim Neal, Sarah Mahoney, Stephane Paulus, Charlotte Castellan, Behrouz Kassai, Johannes N van den Anker, Gregory L Kearns and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2014. 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 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 6% 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.

NCT03113344 unknown statusnot on this mapstarted 2017, after this paper: background citation

Population Pharmacokinetics of Anti-infective Drugs in Children in Anti-infectious Therapies

Typeobservational_patient_registrySponsorBeijing Children's HospitalRan2017 to 2025Enrolled800ConditionsChildren, InfectionArmscephalosporins,penicillins,macrolides,carbapenems and antiviral drugs
NCT03643497 unknown statusnot on this mapstarted 2018, after this paper: background citation

Population Pharmacokinetics of Meropenem and Linezolid in Children With Severe Infectious Diseases

Typeobservational_patient_registrySponsorBeijing Children's HospitalRan2018 to 2021Enrolled800ConditionsChildren;InfectionArmsanti-infective drugs
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Article
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  8. CDC Guidelines for the Prevention and Treatment of Anthrax, 2023.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2023
    Article
  9. Review
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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 9 institutions in 6 countries.

Wei ZhaoDepartment of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China Department of Paediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France Clinical Investigation Center CIC1426, INSERM, Paris, France EA7323, Université Paris Diderot-Université Paris Descartes, Paris, France.
Helen HillDepartment of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom Neonatal Unit, Liverpool Women's Hospital, Liverpool, United Kingdom.
Chantal Le GuellecEA4245, Faculté de Médecine, Université François Rabelais, Tours, France.
Tim NealDepartment of Medical Microbiology, Royal Liverpool University Hospital, Liverpool, United Kingdom.
Sarah MahoneyPaediatric Intensive Care, Alder Hey Children's Hospital, Liverpool, United Kingdom.
Stephane PaulusPaediatric Intensive Care, Alder Hey Children's Hospital, Liverpool, United Kingdom.
Charlotte CastellanCNRS UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Université de Lyon, EPICIME-CIC 1407-INSERM-Hospices Civils de Lyon, Lyon, France.
Behrouz KassaiCNRS UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Université de Lyon, EPICIME-CIC 1407-INSERM-Hospices Civils de Lyon, Lyon, France.
Johannes N van den AnkerIntensive Care, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands Division of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA Departments of Pediatrics, Pharmacology, and Physiology, George Washington University, School of Medicine and Health Sciences, Washington, DC, USA Department of Paediatric Pharmacology, University Children's Hospital Basel, Basel, Switzerland.
Gregory L KearnsDivision of Clinical Pharmacology and Therapeutic Innovation, Children's Mercy Hospital, Kansas City, Missouri, USA Department of Pediatrics, University of Missouri-Kansas City, Kansas City, Missouri, USA.
Mark A TurnerDepartment of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom Neonatal Unit, Liverpool Women's Hospital, Liverpool, United Kingdom.
Evelyne Jacqz-AigrainDepartment of Paediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France Clinical Investigation Center CIC1426, INSERM, Paris, France EA7323, Université Paris Diderot-Université Paris Descartes, Paris, France evelyne.jacqz-aigrain@rdb.aphp.fr.
TINN Consortium
University of Liverpool · GBLiverpool Women's Hospital · GBChildren's Mercy Hospital · USHôpital Robert-Debré · FRHospices Civils de Lyon · FRInserm · FRUniversité de Tours · FRUniversité Paris Cité · FRUniversity Children’s Hospital Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ciprofloxacin is used in neonates with suspected or documented Gram-negative serious infections. Currently, its use is off-label partly because of lack of pharmacokinetic studies. Within the FP7 EU project TINN (Treat Infection in NeoNates), our aim was to evaluate the population pharmacokinetics of ciprofloxacin in neonates and young infants <3 months of age and define the appropriate dose in order to optimize ciprofloxacin treatment in this vulnerable population. Blood samples were collected from neonates treated with ciprofloxacin and concentrations were quantified by high-pressure liquid chromatography-mass spectrometry. Population pharmacokinetic analysis was performed using NONMEM software. The data from 60 newborn infants (postmenstrual age [PMA] range, 24.9 to 47.9 weeks) were available for population pharmacokinetic analysis. A two-compartment model with first-order elimination showed the best fit with the data. A covariate analysis identified that gestational age, postnatal age, current weight, serum creatinine concentration, and use of inotropes had a significant impact on ciprofloxacin pharmacokinetics. Monte Carlo simulation demonstrated that 90% of hypothetical newborns with a PMA of <34 weeks treated with 7.5 mg/kg twice daily and 84% of newborns with a PMA ≥34 weeks and young infants receiving 12.5 mg/kg twice daily would reach the AUC/MIC target of 125, using the standard EUCAST MIC susceptibility breakpoint of 0.5 mg/liter. The associated risks of overdose for the proposed dosing regimen were <8%. The population pharmacokinetics of ciprofloxacin was evaluated in neonates and young infants <3 months old, and a dosing regimen was established based on simulation.

Indexed as

Anti-Bacterial AgentsArea Under CurveBody WeightCardiotonic AgentsChromatography, High Pressure LiquidCiprofloxacinCreatinineDose-Response Relationship, DrugFemaleGestational AgeGram-Negative BacteriaGram-Negative Bacterial InfectionsHumansInfantInfant, NewbornIntensive Care, NeonatalAnti-Bacterial AgentsCardiotonic AgentsCiprofloxacinCreatinine

Identifiers

PMID25155587
PMCPMC4249352
OpenAlexW2070015783

What OpenQuestion holds

Textmetadata
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.