Effect of Inflammation on Pharmacokinetics of Posaconazole

Completed

• Conditions: Mycoses
• Interventions: Drug: posaconazole

• Registration Number: NCT02492802
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.

Detailed Description

A prospective observational study will be performed at the University Medical Center Groningen, the Netherlands using longitudinal data collection. The design of the study will be that patients starting on posaconazole treatment will be evaluated. After informed consent is obtained medical data will be collected from the medical chart. Posaconazole plasma concentration (trough levels) and inflammatory markers (e.g. C-reactive protein) will be determined in all samples available from routine analysis (often daily). This will result in a detailed data set capturing day to day variations in inflammation and drug concentrations.

Study Timeline

• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-09
• Study Start: 2015-08-13
• Primary Completion: 2017-06-01
• Study Completion: 2017-08-01
• Results First Submitted: 2018-02-07
• Results First Submitted QC: 2019-03-04
• Results First Posted: 2019-06-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• >18 yrs
• receiving posaconazole
• Written informed consent

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
posaconazole-group	posaconazole	patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection

Primary Outcome Measures

Name	Time	Method
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L	6 months after start of treatment	Posaconazole drug exposure during treatment in different stages of inflammation. To determine the differences in concentrations between patients a random additive effect was used. Additionally, to correct for differences in intervals between observations a first-order autoregressive correlation was used. The Wald type III test was used to assess the influence of inflammation on posaconazole concentration.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands