Bacterial infection, skin infection, bone infection Bacterial infection
Conditions
Interventions
Flucloxacillin (Floxapen) suspension, dosed according to Dutch pediatric children formulary. 
Sponsors
HagaZiekenhuis
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:Age 1 month to 11 yearsDiagnosed with (probable) infection with a gram-positive bacterium (airway, bone, or skin infection; infection without a clear focus)Able to receive oral medication
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Initiation of flucloxacillin therapy prior to study participation.History of penicillin or cephalosporin allergy.Severe vomiting or diarrhea.Drugs displaying drug-drug interactions with flucloxacillin which may affect the pharmacokinetics of flucloxacillin, including: acetylsalicylic acid, indomethacin, phenylbutazone, and probenecid.Drugs displaying drug-drug interactions with flucloxacillin which may affect the pharmacokinetics of the co-administered drug in a clinically relevant manner, including: everolimus, tacrolimus, sirolimus, ciclosporin, isavuconazole, posaconazole, voriconazole, itraconazole, fluconazole, carbamazepine, valproic acid, clozapine, acenocoumarol, phenprocoumon and quinidine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters: Blood concentration of flucloxacillinEndpoint/target deliverable:Population pharmacokinetic model for oral flucloxacillin in children.Novel dosing regimens obtaining a 95% chance of target attainment of fT% > MIC of 40% and 100%. | — |
Countries
Netherlands
Contacts
Public ContactM.D. Kruizinga
HagaZiekenhuis
Outcome results
None listed