Effect of Inflammation on Pharmacokinetics of Posaconazole
1 other identifier
observational
64
1 country
1
Brief Summary
Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedStudy Start
First participant enrolled
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
June 7, 2019
CompletedAugust 6, 2019
July 1, 2019
1.8 years
July 2, 2015
February 7, 2018
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
posaconazole-group
patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection
Interventions
collection plasma samples for measuring posaconazole drug concentration
Eligibility Criteria
* patients with hematological malignancies * immunocompromised patients
You may qualify if:
- \>18 yrs
- receiving posaconazole
- Written informed consent
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jan-Willem Alffenaar, PhD
- Organization
- University Medical Center Groningen
Study Officials
- PRINCIPAL INVESTIGATOR
Jan-Willem Alffenaar, PharmD, PhD
University Medical Center Groningen
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD PhD
Study Record Dates
First Submitted
July 2, 2015
First Posted
July 9, 2015
Study Start
August 13, 2015
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
August 6, 2019
Results First Posted
June 7, 2019
Record last verified: 2019-07