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Completed

NCT Number: NCT01418846

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

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.

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Key information

Conditions

Pneumology Hematology Internal Medicine Pediatrics

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Brussels - Cystic Fibrosis Clinic, Brussels, Brussels Capital, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Voriconazole pharmacokinetics in saliva and plasma in different patient populations

    Time frame: One day at steady state of voriconazole plasma levels

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2011
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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