Evidence map›Paper›PMID 38365814›Full record

Trial reportTrials2024

Impact of model-informed precision dosing in adults receiving vancomycin via continuous infusion: a randomized, controlled clinical trial.

Glenn Van Wynsberge, Veerle Grootaert, Franky Buyle, Jens Van Praet, Roos Colman, Ine Moors, Annemie Somers, Diana Huis In 't Veld, Pieter De Cock, VANC-DOS Consortium

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05535075 (Impact of Model-informed Precision Dosing of Vancomycin in Adults), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 19% 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.

NCT05535075 phase4completednot on this map

Impact of Model-informed Precision Dosing of Vancomycin in Adults: a Randomized, Clinical Trial

TypeinterventionalSponsorUniversity Hospital, GhentRan2021 to 2023Enrolled155ConditionsVancomycinArmsVancomycin model-informed precision dosing, Vancomycin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
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

10 authors at 3 institutions in 1 country.

Glenn Van WynsbergeDepartment of Pharmacy, Ghent University Hospital, Ghent, Belgium.
Veerle GrootaertDepartment of Pharmacy, General Hospital Sint-Jan Bruges, Bruges, Belgium.
Franky BuyleDepartment of Pharmacy, Ghent University Hospital, Ghent, Belgium.
Jens Van PraetDepartment of Nephrology and Infectious Diseases, General Hospital Sint-Jan Bruges, Bruges, Belgium.
Roos ColmanBiostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
Ine MoorsDepartment of Hematology, Ghent University Hospital, Ghent, Belgium.
Annemie SomersDepartment of Pharmacy, Ghent University Hospital, Ghent, Belgium.
Diana Huis In 't VeldDepartment of General Internal Medicine and Infectious Diseases, Ghent University Hospital, Ghent, Belgium.
Pieter De CockDepartment of Pharmacy, Ghent University Hospital, Ghent, Belgium. pieter.decock@uzgent.be.ORCID http://orcid.org/0000-0001-7634-7471
VANC-DOS Consortium
Ghent University Hospital · BEAZ Sint-Jan · BEGhent University · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVancomycin is a commonly prescribed antibiotic to treat gram-positive infections. The efficacy of vancomycin is known to be directly related to the pharmacokinetic/pharmacodynamic (PK/PD) index of the area under the concentration-time curve (AUC) divided by the minimal inhibitory concentration (MIC) of the pathogen. However, in most countries, steady-state plasma concentrations are used as a surrogate parameter of target AUC/MIC, but this practice has some drawbacks. Hence, direct AUC-guided monitoring of vancomycin using model-informed precision dosing (MIPD) tools has been proposed for earlier attainment of target concentrations and reducing vancomycin-related nephrotoxicity. However, solid scientific evidence for these benefits in clinical practice is still lacking. This randomized controlled trial (RCT) aims to investigate the clinical utility of MIPD dosing of vancomycin administered via continuous infusion in hospitalized adults.

methodsParticipants from 11 wards at two Belgian hospitals are randomly allocated to the intervention group or the standard-of-care comparator group. In the intervention group, clinical pharmacists perform dose calculations using CE-labeled MIPD software and target an AUC24h of 400 to 600 mg × h/L, whereas patients in the comparator group receive standard-of-care dosing and monitoring according to the institutional guidelines. The primary endpoint is the proportion of patients reaching the target AUC24h/MIC of 400-600 between 48 and 72 h after start of vancomycin treatment. Secondary endpoints are the proportion of patients with (worsening) acute kidney injury (AKI) during and until 48 h after stop of vancomycin treatment, the proportion of patients reaching target AUC24h/MIC of 400-600 between 72 and 96 h after start of vancomycin treatment, and the proportion of time within the target AUC24h/MIC of 400-600. DISCUSSION: This trial will clarify the propagated benefits and provide new insights into how to optimally monitor vancomycin treatment.

trial registrationEudraCT number: 2021-003670-31. Registered June 28, 2021. CLINICALTRIALS: gov identifier: NCT05535075. Registered September 10, 2022. Protocol version 3, protocol date: April 21, 2023.

Indexed as

Anti-Bacterial AgentsVancomycinAdultArea Under CurveHealth FacilitiesHumansMicrobial Sensitivity TestsAnti-Bacterial AgentsVancomycinAntibioticContinuous infusionModel-informed precision dosingRandomized controlled trialTherapeutic drug monitoringVancomycin

Identifiers

PMID38365814
PMCPMC10870500
OpenAlexW4391882046

What OpenQuestion holds

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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.