Evaluation of a new Dutch vancomycin dosage guideline in preterm and term neonates.

Completed

• Conditions: Antibiotic treatment; 10004018

• Registration Number: NL-OMON42496
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Treatment with vancomycin i.v. starting dose according to hospital guidelines (table 1) for a clinically suspected or proven infection
- Signed informed consent from parents or legal guardians

Exclusion Criteria

- Parent refusal
- Inability to monitor drug levels during treatment
- Inability to sample blood

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is the number of therapeutic first vancomycin trough<br /><br>levels, when receiving the earlier mentioned starting doses. Furthermore, the<br /><br>number of sub- and supra-therapeutic first trough levels will be determined as<br /><br>well. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter is the determination of inter-patient variability in<br /><br>population pharmacokinetic parameters and drug exposure/MIC, expressed as<br /><br>AUC/MIC. Availability of these parameters will allow further improvement of the<br /><br>dosage regimens. </p><br>