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Pharmacokinetics of micafungin in critically ill patients with invasive candidiasis.

Phase 4
Completed
Conditions
Invasive candidiasis
invasive fungal infection
10017528
Registration Number
NL-OMON37779
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

Treatment with micafungin
Admission to an ICU
Age >= 18 years
Invasive candidiasis

Exclusion Criteria

Blood sampling not possible.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter is the correlation of the pharmacokinetic parameters<br /><br>and plasma concentration of micafungin with disease severity scores.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1) Pharmacokinetic parameters of micafungin in ICU patients.<br /><br>2) Time (in days) to culture conversion.<br /><br>3) Correlation of the plasma concentration of micafungin with response to<br /><br>treatment.<br /><br>4) Correlation of the plasma concentration of micafungin with inflammation<br /><br>parameters.<br /><br>5) AUC/MIC ratio and Cmax/MIC ratio.<br /><br>6) Constructing a pharmacokinetic model of micafungin in critically ill<br /><br>patients.</p><br>
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