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Comparison of Two Dosage Adjustment Strategies of Vancomycin in Children

NCT02694458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-27

No results posted yet for this study

Summary

Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric therapy. The relationship between exposure to vancomycin and efficacy is admitted but because of an important intersubject variability, therapeutic exposure isn't usually achieved.

The primary aim of this randomized controlled trial is to evaluate a new early dosage adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy.

Using a bayesian approach, the purpose is to achieve earlier a therapeutic and non-toxic exposure to vancomycin.

The primary hypothesis is that an early dosage adjustment strategy using a bayesian approach will allow patients to achieve the vancomycin pharmacological target faster than with the usual treatment strategy.

Conditions

  • Methicillin-resistant Staphylococcal Infections

Interventions

OTHER

Early vancomycin monitoring and bayesian dosage adjustment

Measure of vancomycin serum concentration at the 3rd hour of treatment and adjustment of vancomycin dosage at the 6th hour of treatment using a bayesian approach. Then measure of vancomycin serum concentration at the 24th hour of treatment.

OTHER

usual vancomycin dose and monitoring strategy

Vancomycin serum concentration will be measured at the 24th hour of treatment.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Marc TRELUYER, MD, PhD · Hôpital Necker-Enfants Malades

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-23
Primary Completion
2017-02-15
Completion
2017-02-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02694458 on ClinicalTrials.gov