Optimalisation of vancomycine dosage regimens in pediatric patients

• Conditions: blood poisoning; serious infection; 10004018

• Registration Number: NL-OMON30777
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- children (age 0 to 18 yrs)
- suspected or proven systemic infection with Gram-positive bacteria (incl. indwelling catheter infection) treated with intravenous vancomycin
- written informed consent signed by both parents or the legal representative(s)

Exclusion Criteria

- renal failure (defined as a plasma creatinine concentration above the age corrected normal value)
- renal replacement therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>During the study the following data will be collected centrally as part of the<br /><br>clinical research file:<br /><br>- length, body weight, age (for neonates also gestational age)<br /><br>- patient category (oncology, intensive car, neonate, other)<br /><br>- renal function (serum creatinine, blood urea nitrogen), fluid balance (if<br /><br>recorded as part of routine care)<br /><br>- reason for starting intravenous vancomycine therapy, dosage (dose en precise<br /><br>times of administration)<br /><br>- vancomycine serum concentrations, precise times of sampling, type of material<br /><br>- body temperature at the time of vancomycin administration<br /><br>- susceptibility and/or MIC of grown pathogens (bacteria)<br /><br>- registration of reported adverse effects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>