Defining the optimal dose for continuous flucloxacillin infusion using pharmacokinetic modelling ;The FLUCON-study

Recruiting

• Conditions: infectional disease; 10004018

• Registration Number: NL-OMON43049
• Lead Sponsor: Deventer Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: Part A: (step 1) A quantitative description of<br /><br>the pharmacokinetics flucloxacillin in non-critically ill patients: changes in<br /><br>(unbound) flucloxacillin level-time profiles and the possible relationship with<br /><br>renal function and demographics. Step 2: A dosing regime for continuous<br /><br>administration of flucloxacillin in which 90% of the population exceeds 100%<br /><br>ft>MIC (with a maximum unbound flucloxacillin concentration of 7,5mg/L). Part<br /><br>B: The percentage of patients exceeding the PK target of 100% ft>MIC (with a<br /><br>maximum unbound flucloxacillin concentration of 7,5mg/L) with the new dosing<br /><br>regime. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part B: A description of the tolerability of the new continuous dosing scheme. </p><br>