Determination of Voriconazole Levels in Saliva - Validati... | NCT01418846

Studies
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients

NCT01418846

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jan 13, 2015Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Pneumology
Hematology
Internal Medicine
Pediatrics

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Aug 16, 2011

First Submission Date that Met QC Criteria

Aug 16, 2011

First Posted Date

Aug 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2015

Last Update Posted Date

Jan 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Voriconazole pharmacokinetics in saliva and plasma in different patient populations		One day at steady state of voriconazole plasma levels

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Vanstraelen, R.Ph.	Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Brussels - Cystic Fibrosis Clinic		Brussels	Brussels Capital	1090	Belgium
Ghent University Hospital - Cystic Fibrosis Clinic

Label	Type	Description	Intervention Names
adult hematology patients
pediatric patients age 5-18years
adult pneumology patients