Effect of Inflammation on Pharmacokinetics of Posaconazole

NCT ID: NCT02492802

Last Updated: 2019-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-13

Study Completion Date

2017-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mycoses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

posaconazole-group

patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection

posaconazole

Intervention Type DRUG

collection plasma samples for measuring posaconazole drug concentration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

posaconazole

collection plasma samples for measuring posaconazole drug concentration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

noxafil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>18 yrs
* receiving posaconazole
* Written informed consent

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jan-Willem C Alffenaar

PharmD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan-Willem Alffenaar, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

POSA-CRP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.