Are fluconazole saliva levels representative for serum levels in children and neonates?
ID
Source
Brief title
Condition
- Fungal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-pharmacokinetics of fluconazole in saliva and serum in children and neonates
-fluconazole saliva/serum concentration ratio in children and neonates.
Secondary outcome
-Efficacy of fluconazole treatment, as measured by negative
(surveillance-)cultures.
-Does fluconazole reach sufficient levels in the gastrointestinal tract when
the administration route is intravenous
Background summary
Amongst children treated in the Beatrix Kinderkliniek (BKK) there are patients,
who are particularly prone to invasive Candida infections with a high risk for
extra morbidity and mortality.[1]
Fluconazole is widely used for treatment of (systemic) yeast infections.[2] It
is also used as prophylaxis in children who are at risk for developing
candidiasis when they are colonised with Candida species.
Monitoring fluconazole concentrations in different body-fluids is indicated in
these patients.
Fluconazole concentration levels can be measured in saliva and there might be a
good correlation with serum concentration levels.[5,6] However, this has rarely
been studied in adults [6] until now and never in children.
We hypothesize that fluconazole saliva levels correlate with serum levels in
children and neonates and can be used for treatment monitoring.
Study objective
Are fluconazole saliva levels representative for serum levels in children and
neonates?
Study design
Prospective observational pharmacokinetic study.
Study burden and risks
Burden to the patient will be that he/she has to chew/suck on a small piece of
cotton for 1-2 minutes. There are no extra risks associated with participation
in this study.
Postbus 30.001
9700 RB Groningen
Nederland
Postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Included are children on oral (with of without enteral tube) or intravenous fluconazole treatment.
Exclusion criteria
Excluded are children from whom it is impossible to get saliva ,or who have, due to their condition, such a serious mucositis of their oral cavity that saliva is mixed with blood, are excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-003198-42-NL |
| CCMO | NL23369.042.08 |