1) Formulating a dose regimen for intravenous infusion of amoxicillin 1) More insight into the pharmacokinetics of amoxicillin in children of ages making more specific dosing possible.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters in this study will be:
* T1/2 (half-life during elimination phase) and Vss (volume of distribution in
steady state) of amoxicillin
* Total body clearance, AUC (area under the time-concentration curve), MRT
(mean residence time)
Interpretation of pharmacokinetic parameters
* Plasma concentrations and the AUC*s of amoxicillin will be compared to the
MIC (minimal inhibitory concentration) of the microbe to be eliminated.
* T1/2 of amoxicillin will be related to the GFR (glomerular filtration)
* All pharmacokinetic parameters will be related to the personal
characteristics of the subjects
Finally, all data will lead to a new dosing advice on intravenous amoxicillin
treatment in children.
Secondary outcome
not applicable
Background summary
Amoxicillin is a bactericide aminopenicillin that is active against
gram-positive and gram-negative organisms and also inhibits β-lactamase-free
strains of H. influenzae, N. gonorrhoea, E. coli, Proteus mirabilis and
Salmonella species. In paediatrics amoxicillin is used in the treatment of
neonatal infections, pneumonias and as a prophylaxis after gastro-intestinal
surgery. Despite this wide use, records from our pharmacy show that, when using
nationwide dosing regimens like the Kinderformularium®, some children receive
higher doses compared to adults. In particular children with a high body mass
index and children above 12 years of age are given high doses amoxicillin. This
population could be overdosed, unnecessarily. Current literature on
pharmacokinetics of amoxicillin use in children is limited to neonates and the
use of amoxicillin for specific indications. There are no pharmacokinetic
studies about amoxicillin in older children despite the vulnerability of
children. In this particular age group it is of great importance to dose with
care in order to reach effective levels without exposing them to high doses.
This study will clarify dosing of amoxicillin in children measuring the plasma
levels and comparing them with the MIC needed to eradicate the micro-organisms
causing infection. By calculating the pharmacokinetics as well, we will be able
to formulate a new dosing regimen for the use of continuous intravenous
infusion of amoxicillin. We expect lower dosing to be possible, in particular
in obese children and children above 12 years of age.
Study objective
1) Formulating a dose regimen for intravenous infusion of amoxicillin
1) More insight into the pharmacokinetics of amoxicillin in children of ages
making more specific dosing possible.
Study design
Observational study
Study burden and risks
Burden
- 3 blood punctures or an extra indwelling needle or three capillary punctures
- total blood taken: 0,85 ml over 5 days
Risks
- pain and fear: will be reduced by using an anesthetic liniment en good
preparation by nurses.
- haematoma
- in neonates: anemia, though not expected because of minimal blood taken and
spread over 5 days
Postbus 9015
6500 GS Nijmegen
NL
Postbus 9015
6500 GS Nijmegen
NL
Listed location countries
Age
Inclusion criteria
1. Patients who receive intravenous treatment with amoxicillin
2. Patients < 18 years
3. Written informed consent from the patient and/or their legal guardian
Exclusion criteria
Patients with a known allergy to amoxicillin or related compounds
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 | EUCTR2009-016147-19-NL |
| CCMO | NL29930.091.09 |