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NCT02492802 Clinical Trial

Effect of Inflammation on Pharmacokinetics of Posaconazole

Mycoses Clinical Trial

Official title:
Effect of Inflammation on Pharmacokinetics of Posaconazole

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02492802
Other study ID # POSA-CRP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 13, 2015
Est. completion date August 1, 2017

Study information
Verified date July 2019
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date August 1, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >18 yrs

- receiving posaconazole

- Written informed consent

Exclusion Criteria:

- none

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• posaconazole
collection plasma samples for measuring posaconazole drug concentration

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L 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. 6 months after start of treatment
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