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Development and validation of a pharmacokinetic model of flucloxacillin for dosing in patients with impaired renal functio

Completed
Conditions
10004018
impaired renal function
ierfunctiestoornissen
Registration Number
NL-OMON41120
Lead Sponsor
Atrium Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

- adults treated with oral or intravenous flucloxacillin
- normal and impaired renal function expressed as MDRD and corrected for BSA (body surface area)

Exclusion Criteria

- patients younger than 18 years of age;
- legally incapable patients;
- contra-indication or allergy to the treatment with flucloxacillin;
- pregnant patients;
- patients receiving dialysis.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study endpoint is the development of a PK-model for dosing of<br /><br>flucloxacillin in patients with impaired renal function.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoint is the predictive value of the model for dosing of<br /><br>flucloxacillin in patients with impaired renal function.</p><br>
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