Evidence map›Paper›PMID 32266599›Full record

Trial reportDrugs in R&D2020

Assessment of Vancomycin Pharmacokinetics and Dose Regimen Optimisation in Preterm Neonates.

Mwila Mulubwa, Heletje Aletta Griesel, Pierre Mugabo, Ricky Dippenaar, Lizelle van Wyk

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drugs in R&D, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
0.4field-weighted citation impact, top 27% 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, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Antibiotic regimens for early-onset neonatal sepsis.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Antibiotic regimens for late-onset neonatal sepsis.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Impact of Extracorporeal Membrane Oxygenation in an Infant Treated with Vancomycin: A Case Report.International journal of environmental research and public health · 2023
    Article
  16. Observational
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

5 authors at 2 institutions in 1 country.

Mwila MulubwaSchool of Pharmacy, University of the Western Cape, Private Bag X17, Bellville, Cape Town, 7535, South Africa. 3579753@myuwc.ac.za.ORCID http://orcid.org/0000-0003-2404-9717
Heletje Aletta GrieselSchool of Pharmacy, University of the Western Cape, Private Bag X17, Bellville, Cape Town, 7535, South Africa.
Pierre MugaboSchool of Pharmacy, University of the Western Cape, Private Bag X17, Bellville, Cape Town, 7535, South Africa.ORCID http://orcid.org/0000-0001-5653-0551
Ricky DippenaarNeonatology Department, Netcare Blaauwberg Hospital, Sunningdale, Cape Town, 7441, South Africa.
Lizelle van WykDivision of Neonatology, Department of Paediatrics and Child Health, Tygerberg Hospital, Stellenbosch University, Cape Town, 7505, South Africa.
University of the Western Cape · ZAStellenbosch University · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe pharmacokinetics of vancomycin, a drug used for the treatment of methicillin-resistant Staphylococcus aureus (MRSA), varies between paediatric and adult patients.

objectiveThe objective of this study was to assess the pharmacokinetics of vancomycin in preterm neonates and determine the optimum dose regimen.

methodsThis was a randomised double-blind study of preterm neonates admitted to neonatal intensive care units. They all received vancomycin 15 mg/kg every 12 h. Blood was sampled just before administration of the third, sixth and ninth vancomycin dose. Pharmacokinetic parameters were estimated using a Bayesian approach implemented in Monolix 2018R2 software. Covariates assessed included postmenstrual age, current weight, creatinine clearance, albumin, gestational age, body surface area and current age. We used Monte Carlo simulations for dose regimen optimisation targeting area under the concentration-time curve up to 24 h (AUC

resultsIn total, 19 preterm neonates were enrolled in the study with a median age of 14 (3-58) days. A one-compartment model with linear elimination best described the pharmacokinetics of vancomycin. Volume of distribution and clearance was 0.88 L and 0.1 L/h, respectively, for a typical neonate weighing 1.48 kg. Simulation of the current dose regimen showed that 27.5% of the neonates would achieve the target AUC

conclusionThe majority of the neonates were under dosed. Vancomycin 12 mg/kg should be administered every 8 h over 1 h infusion to improve the likelihood of achieving the AUC

Indexed as

Anti-Bacterial AgentsDose-Response Relationship, DrugDouble-Blind MethodHumansInfant, NewbornInfant, PrematureInfant, Premature, DiseasesIntensive Care Units, NeonatalMethicillin-Resistant Staphylococcus aureusMicrobial Sensitivity TestsMonte Carlo MethodStaphylococcal InfectionsTissue DistributionVancomycinAnti-Bacterial AgentsVancomycin

Identifiers

PMID32266599
PMCPMC7221111
OpenAlexW3014999727

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.