PneumologyNCT01418846
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients
An observational study of Pneumology and Hematology, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Pneumology, Hematology, Internal Medicine
- How many people
- 11 participants
- Where
- 3 sitesBelgium
- Study dates
- Oct 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized at the pneumology ward, adult hematology ward and all hospitalized pediatric patients, treated with voriconazole.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
University Hospital Brussels - Cystic Fibrosis Clinic
Brussels, Brussels Capital, 1090
Ghent University Hospital - Cystic Fibrosis Clinic
Ghent, East Flanders, 9000
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: 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.
- Conditions
- Pneumology, Hematology, Internal Medicine, Pediatrics
- Keywords
- voriconazole, saliva, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult hematology patients | Not described | |
| pediatric patients age 5-18years | Not described | |
| adult pneumology patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voriconazole pharmacokinetics in saliva and plasma in different patient populations
Measured: One day at steady state of voriconazole plasma levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumologyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Vanstraelen, R.Ph., Principal investigator, Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418846
- Sponsor's protocol ID
- ML7401
- Status last verified
- Feb 2013
- First submitted
- 16 Aug 2011
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.
- ClinicalTrials.gov ID
- NCT01418846
- Acronym / sponsor ID
- ML7401
- Conditions
- Pneumology, Hematology, Internal Medicine, Pediatrics
- Keywords
- voriconazole, saliva, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adult hematology patients | – | – |
| pediatric patients age 5-18years | – | – |
| adult pneumology patients | – | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized at the pneumology ward, adult hematology ward and all hospitalized pediatric patients, treated with voriconazole.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Voriconazole pharmacokinetics in saliva and plasma in different patient populations
Time frame: One day at steady state of voriconazole plasma levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Related trials for Pneumology
Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Innate Immunity, Mucosal Immunity
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Not yet recruitingObservational study
Chinese Hemoptysis Registry Study
Hemoptysis
Not yet recruitingObservational study
COINCIDE: Cardineurovascular dIsease and Obstructive Airway Disease
Chronic Obstructive Pulmonary Disease (COPD), Severe Asthma
Recruiting
Acoustic Waveform Respiratory Evaluation
Asthma, COPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Vanstraelen, R.Ph. principal investigator
Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumology and Hematology, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voriconazole pharmacokinetics in saliva and plasma in different patient populations (time frame: One day at steady state of voriconazole plasma levels). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.