Effect of Inflammation on Pharmacokinetics of Posaconazole

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 1, 2017

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.

Interventions

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

Arms, Groups and Cohorts

  • posaconazole-group
    • patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection

Clinical Trial Outcome Measures

Primary Measures

  • C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • >18 yrs – receiving posaconazole – Written informed consent Exclusion Criteria:

  • none

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Center Groningen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jan-Willem C Alffenaar, PharmD PhD – University Medical Center Groningen
  • Overall Official(s)
    • Jan-Willem Alffenaar, PharmD, PhD, Principal Investigator, UMCG

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