NCT01418846

Brief Summary

The purpose of this study is to investigate the intra-saliva penetration of voriconazole in different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in children, ambulatory patients and in patients in whom blood drawing is difficult.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 13, 2015

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

August 16, 2011

Last Update Submit

January 12, 2015

Conditions

PneumologyHematologyInternal MedicinePediatrics

Keywords

voriconazolesalivapharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Voriconazole pharmacokinetics in saliva and plasma in different patient populations

    One day at steady state of voriconazole plasma levels

Study Arms (3)

adult hematology patients

pediatric patients age 5-18years

adult pneumology patients

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized at the pneumology ward, adult hematology ward and all hospitalized pediatric patients, treated with voriconazole.

You may qualify if:

  • patients from the adult hematology ward treated with voriconazole
  • pediatric patients treated with voriconazole, age 5-18 years
  • patients from the pneumology ward treated with voriconazole

You may not qualify if:

  • Age under 5 years
  • Women who are pregnant or lactating
  • Mucositis stage 3 or 4 (WHO)
  • Patients which received the following drugs within 14 days before study entry: rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz and barbiturates.
  • Patients which received the following drugs within 24hours before study entry: quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, ritonavir and sulphonylureas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Brussels - Cystic Fibrosis Clinic

Brussels, Brussels Capital, 1090, Belgium

Location

Ghent University Hospital - Cystic Fibrosis Clinic

Ghent, East Flanders, 9000, Belgium

Location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

  • Kim Vanstraelen, R.Ph.

    Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 17, 2011

Study Start

October 1, 2012

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

January 13, 2015

Record last verified: 2013-02

Locations

BE(3)