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Gentamicin concentrations in saliva in neonates


- candidate number29280
- NTR NumberNTR7410
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jul-2018
- Secondary IDsCHDR1816 / NL66410.018.18 toetsingonline
- Public TitleGentamicin concentrations in saliva in neonates
- Scientific TitleModelling of saliva gentamicin concentrations in neonates receiving gentamicin treatment
- ACRONYMSaliva gentamicin concentrations in neonates
- hypothesisThis study aims to determine a correlation between saliva and plasma gentamicin concentra-tions in different neonatal subgroups. The relationship between gentamicin concentrations in plasma and saliva will be described by a population PK model.
- Healt Condition(s) or Problem(s) studiedNeonatal sepsis, Gentamicin concentrations
- Inclusion criteria1. Signed informed consent from both parents prior to any study-mandated procedure.
2. Admission to the neonatology ward of AMC
3. Gentamicin treatment
- Exclusion criteria1. Congenital disease of the salivary glands
2. Parent refusal
3. Inability to sample saliva
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 28-jul-2018
- planned closingdate1-jan-2019
- Target number of participants60
- InterventionsNA
- Primary outcomeGentamicin concentration in saliva and plasma
- Secondary outcomeNA
- TimepointsGroup 1: after 1, 4, 24, 37.5, 48, 49, 51, 60, 72, 84, 95.5, 96 hours
Group 2: after 1, 4, 12, 35.5, 36, 37, 39, 48, 54, 60, 71.5, 72 hours
Group 3: after 1, 4, 12, 23.5, 24, 25, 27, 36, 42, 47.5, 48 hours
- Trial web siteNA
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. R.A.A. (Ron) Mathôt
- CONTACT for SCIENTIFIC QUERIESProf. dr. R.A.A. (Ron) Mathôt
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
First flow of funds
- PublicationsNA
- Brief summaryIn neonatology wards, neonates are often admitted due to suspected infection. In the Nether-lands, neonatologists often prescribe the aminoglycoside antibiotic gentamicin. Gentamicin has a small therapeutic index and therefore, therapeutic drug monitoring has to be performed. This is done by taking two blood samples (peak and trough levels), which causes a consider-able burden for the neonate. Therefore, a non-invasive method of therapeutic drug monitoring, for example in saliva, may be beneficial.
In the past, investigators have attempted to measure gentamicin concentration in saliva, with conflicting results. Berkovitch et al. demonstrated a good correlation between saliva and serum concentrations when gentamicin was administered once daily. However, when using shorter dose-intervals, a significant correlation could not be established.
This study aims to determine a correlation between saliva and plasma gentamicin concentra-tions in different neonatal subgroups. The relationship between gentamicin concentrations in plasma and saliva will be described by a population PK model.
- Main changes (audit trail)
- RECORD17-jul-2018 - 10-aug-2018


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