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Trial record 9 of 530 for:    VANCOMYCIN

Exploring Vancomycin Disposition in Neonates

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ClinicalTrials.gov Identifier: NCT02096536
Recruitment Status : Unknown
Verified November 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : March 26, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neonatal Infection Drug: Vancomycin Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploring Vancomycin Disposition in Neonates: Paired Analysis of Vancomycin Concentrations Using Immunoassay and Liquid-chromatography-tandem Mass Spectrometry. Determination of Vancomycin Protein Binding and Its Covariates in Neonates
Study Start Date : April 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Vancomycin
All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.
Drug: Vancomycin
vancomycin administration based on decision of treating physician
Other Name: Vancomycine Actavis




Primary Outcome Measures :
  1. Differences in vancomycin exposure [ Time Frame: 1 year ]

    Paired vancomycin concentrations in 60 neonates using an immunoassay versus LC/MS-MS method.

    Total versus unbound vancomycin concentrations in 60 neonates.



Secondary Outcome Measures :
  1. Impact of freezing and thawing on vancomycin measurement [ Time Frame: 1 year ]
    Comparisson of the same analytical technique (immunoassay) in fresh (routine clinical care) versus stored samples .



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Ages Eligible for Study:   up to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096536


Contacts
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Contact: Anne Smits, MD 003216341564 anne.smits@uzleuven.be
Contact: Karel Allegaert, MD, PhD 003216343210 karel.allegaert@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Anne Smits, MD    003216341564    anne.smits@uzleuven.be   
Contact: Karel Allegaert, MD,PhD    003216343210    karel.allegaert@uzleuven.be   
Sub-Investigator: Karel Allegaert, MD, PhD         
Principal Investigator: Anne Smits, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Anne Smits, MD UZ Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02096536     History of Changes
Other Study ID Numbers: S56376
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015
Keywords provided by Universitaire Ziekenhuizen Leuven:
Neonate
Vancomycin
LC/MS-MS
protein binding
Additional relevant MeSH terms:
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Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents