Evidence map›Paper›PMID 34625981›Full record

Observational studyBritish journal of clinical pharmacology2022

Saliva as a sampling matrix for therapeutic drug monitoring of gentamicin in neonates: A prospective population pharmacokinetic and simulation study.

Amadou Samb, Matthijs Kruizinga, Younes Tallahi, Michiel van Esdonk, Willemijn van Heel, Gertjan Driessen, Yuma Bijleveld, Rik Stuurman, Adam Cohen, Anton van Kaam and 2 more

Open access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 15% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. 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

12 authors at 6 institutions in 1 country.

Amadou SambDepartment of Pharmacy and Clinical Pharmacology, Amsterdam UMC, Amsterdam, the Netherlands.ORCID 0000-0003-2354-4361
Matthijs KruizingaCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0002-2054-2187
Younes TallahiDepartment of Pharmacy and Clinical Pharmacology, Amsterdam UMC, Amsterdam, the Netherlands.
Michiel van EsdonkCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0001-8159-0273
Willemijn van HeelJuliana Children's Hospital, HAGA Teaching Hospital, The Hague, the Netherlands.
Gertjan DriessenJuliana Children's Hospital, HAGA Teaching Hospital, The Hague, the Netherlands.
Yuma BijleveldDepartment of Pharmacy and Clinical Pharmacology, Amsterdam UMC, Amsterdam, the Netherlands.
Rik StuurmanCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0002-0013-8355
Adam CohenCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0001-7452-6222
Anton van KaamDepartment of Neonatology, Emma Children's Hospital Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Timo R de HaanDepartment of Neonatology, Emma Children's Hospital Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Ron MathôtDepartment of Pharmacy and Clinical Pharmacology, Amsterdam UMC, Amsterdam, the Netherlands.
Amsterdam Neuroscience · NLLeiden University Medical Center · NLEmma Kinderziekenhuis · NLCentre for Human Drug Research · NLHaga Hospital · NLMaastricht University Medical Centre · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTherapeutic drug monitoring (TDM) of gentamicin in neonates is recommended for safe and effective dosing and is currently performed by plasma sampling, which is an invasive and painful procedure. In this study, feasibility of a non-invasive gentamicin TDM strategy using saliva was investigated.

methodsThis was a multicentre, prospective, observational cohort study including 54 neonates. Any neonate treated with intravenous gentamicin was eligible for the study. Up to eight saliva samples were collected per patient at different time-points. Gentamicin levels in saliva were determined with liquid chromatography tandem mass-spectrometry (LC-MS/MS). A population pharmacokinetic (PK) model was developed using nonlinear mixed-effects modelling (NONMEM) to describe the relation between gentamicin concentrations in saliva and plasma. Monte Carlo simulations with a representative virtual cohort (n = 3000) were performed to evaluate the probability of target attainment with saliva versus plasma TDM.

resultsPlasma PK was adequately described with an earlier published model. An additional saliva compartment describing the salivary gentamicin concentrations was appended to the model with first-order input (k

conclusionTDM of gentamicin using saliva is feasible and the difference in precision between saliva and plasma TDM may not be clinically relevant, especially for premature neonates.

Indexed as

Drug MonitoringGentamicinsAnti-Bacterial AgentsChromatography, LiquidHumansInfant, NewbornProspective StudiesSalivaTandem Mass SpectrometryAnti-Bacterial AgentsGentamicinsgentamicinneonatesnon-invasivepopulation pharmacokineticssalivasimulationtherapeutic drug monitoring

Identifiers

PMID34625981
PMCPMC9298055
OpenAlexW3203700730

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.