Defining the optimal dose for continuous flucloxacillin infusion

Defining the optimal dose for continuous infusion using pharmacokinetic modelling

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28330

Enrollment

Registered

2016-06-10

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infections kinetics infusion flucloxacillin

Interventions

Part A: none Part B: altered dosage flucloxacillin

Eligibility

Inclusion criteria

Inclusion criteria: - The patient is at least 18 years of age - The patient has started with intravenous flucloxacillin as indicated by their physician Part B 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: The patient who is admitted to the intensive care unit - Pregnant women

Design outcomes

Primary

Measure	Time frame
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. Part B: The percentage of patients exceeding the PK target of 100% fT>MIC with the new dosing regime.	—

Measure

Time frame

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. Part B: The percentage of patients exceeding the PK target of 100% fT>MIC with the new dosing regime.

—

Secondary

Measure	Time frame
Part B: A description of the tolerability of the new continuous dosing scheme.	—

Contacts

Public ContactSarah Wilkes

Nico Bolkesteinlaan 75

E: s.wilkes@dz.nlT: (0570) 53 6242

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)