infectional disease
Conditions
Interventions
Part B: Patients will receive the new dosing scheme for continuous
flucloxacillin therapy and TDM will be conducted.
Sponsors
Deventer Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part A;In order to be eligible to participate in this study, a subject must meet;all of the following criteria:;- The patient is at least 18 years of age;- The patient has started with intravenous flucloxacillin as indicated by;their physician;At least 10 of the 30 patients are treated with flucloxacillin for a bacteriemia;Part B;In order to be eligible to participate in this study, a subject must meet;all of the following criteria:;- The patient is at least 18 years of age;- The patient has an indication for the treatment of flucloxacillin with;continuous infusion as indicated by their physician
Exclusion criteria
Exclusion criteria: Part A and B;A potential subject who meets any of the following criteria will be;excluded from participation in this study because of the altered;pharmacokinetics:;- The patient who is admitted to the intensive care unit;- Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: Part A: (step 1) A quantitative description of the pharmacokinetics flucloxacillin in non-critically ill patients: changes in (unbound) flucloxacillin level-time profiles and the possible relationship with renal function and demographics. Step 2: A dosing regime for continuous administration of flucloxacillin in which 90% of the population exceeds 100% ft>MIC (with a maximum unbound flucloxacillin concentration of 7,5mg/L). Part B: The percentage of patients exceeding the PK target of 100% ft>MIC (with a maximum unbound flucloxacillin concentration of 7,5mg/L) with the new dosing regime. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part B: A description of the tolerability of the new continuous dosing scheme. | — |
Countries
Netherlands
Outcome results
None listed