Influence of flucloxacillin treatment on plasma concentration of CYP - and UGT-substrate drugs.

• Conditions: infection; Staphylococcus Aureus infection; 10004018

• Registration Number: NL-OMON56926
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Aged >=18 years
- Treated with >=6 grams/24h flucloxacillin iv (or equivalent dose in case of
renal impairment) for an intended duration of at least 10 days.
- Concomitant treatment with at least one of the following substrate drugs at
the moment of patient selection: diclofenac, metoprolol, oxycodone extended
release tablet, pantoprazole or paracetamol.
- Written informed consent.

Exclusion Criteria

- Concomitant use of specific CYP-, UGT- and P-gp inducers and inhibitors (see
table S1 in the supplementary material of the study protocol).
- Pregnancy
- Dialysis patients
- Dementia
- IC-admission

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoint:<br /><br>The main study endpoint is the difference in AUC of each substrate drug<br /><br>(diclofenac, metoprolol, oxycodone, pantoprazole and paracetamol) between day<br /><br>1/2 and day 10 (+/- 3 days) of flucloxacillin treatment.<br /><br><br /><br>Parameter:<br /><br>Total substrate drug plasma concentration at specific time points (see section<br /><br>7.3: study procedures). </p><br>