Primary ObjectiveTo establish whether saliva samples could be used as an alternative for blood samples in the therapeutic drug monitoring for gentamicin. To meet this objective, the development of a pharmacokinetic model predicting serum gentamicin…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Description of the concentration-time profile of saliva gentamicin levels in
neonates.
Secondary outcome
The development of a valid population PK model which can predict serum
gentamicin concentrations based on gentamicin concentrations in saliva.
If a fitting model is obtained: assessment of the dosing advice that a hospital
pharmacist would come to based on serum gentamicin concentrations predicted by
the model.
Background summary
In neonatology departments, gentamicin is often used as antimicrobial agent for
treatment of infectious disease. As gentamicin has small therapeutic index,
therapeutic drug monitoring needs to be performed when treating with
gentamicin. Blood samples need to be taken for therapeutic drug monitoring,
causing considerable burden for the neonates concerned. Hence a non-invasive
procedure to perform therapeutic drug monitoring would be of great benefit.
Study objective
Primary Objective
To establish whether saliva samples could be used as an alternative for blood
samples in the therapeutic drug monitoring for gentamicin. To meet this
objective, the development of a pharmacokinetic model predicting serum
gentamicin concentrations from measured saliva concentrations will be attempted.
Secondary objective
If a valid pharmacokinetic model is obtained:
- To establish whether a pharmacist would come to a safe dosing advice using
the serum gentamicin concentrations predicted by the population PK model.
- To assess the difference between the actual dosing advice (based on serum
samples) and the fictive dosing advice (based on saliva samples and the PK
model).
Study design
Observational Cohort study
Study burden and risks
The burden caused by administration of a drop of citrate and by saliva sampling
is minimal. (Prior studies have been executed in a similar fashion, and the
investigators involved were not under the impression that these were
burdensome).
Administration of citrate as well as obtaining saliva samples is without any
risk.
Zernikedreef 10
2333 CL Leiden
Nederland
Zernikedreef 10
2333 CL Leiden
Nederland
Listed location countries
Age
Inclusion criteria
•Term or preterm infants with a postnatal age <= 28 days
•Receiving treatment with gentamicin
•Written informed consent from parents having parental responsibility or from the legal guardian.
Exclusion criteria
•Infant suspected of or suffering from necrotizing enterocolitis
Design
Recruitment
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 |
|---|---|
| CCMO | NL21320.058.08 |