Exploring Vancomycin Disposition in Neonates

Universitaire Ziekenhuizen KU Leuven

Status and phase: Enrolling; Phase 4

Conditions: Neonatal Infection

Treatments: Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02096536

S56376

Details and patient eligibility

About

Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population. The purpose of this study is first of all to perform a paired analysis of serum vancomycin concentrations using an immunoassay versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to determine vancomycin protein binding and its covariates in neonates.

Full description

Exploration of vancomycin disposition in neonates:

Objective 1: Paired analysis of (total) serum vancomycin concentrations in neonates using the currently available immunoassay (Cobas c702) versus a reference liquid chromatography-tandem mass spectrometry method (LC-MS/MS).

Objective 2: The determination of vancomycin protein binding and its covariates in neonates.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 day to 23 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates, admitted to the Neonatal Intensive Care Unit to whom vancomycin is administered for medical reasons, can be included in the study after informed consent of the parents.

Exclusion criteria

• No vancomycin therapy
• No signed informed consent available

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Vancomycin

Other group

Description:

All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.

Treatment:

Drug: Vancomycin