Effect of Inflammation on Pharmacokinetics of Posaconazole

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

Study Overview

• Status: Completed
• Conditions: Mycoses
• Intervention / Treatment: Drug: posaconazole

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 Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• patients with hematological malignancies
• immunocompromised patients

Description

Inclusion Criteria:

• >18 yrs
• receiving posaconazole
• Written informed consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
posaconazole-group; patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection	Drug: posaconazole; collection plasma samples for measuring posaconazole drug concentration; Other Names: noxafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Jan-Willem Alffenaar, PharmD, PhD, UMCG

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Bacterial Infections and Mycoses; Inflammation; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; 14-alpha Demethylase Inhibitors; Trypanocidal Agents; Posaconazole
• Other Study ID Numbers: POSA-CRP