Bacterial Infections Clinical Trial
— FANATICOfficial title:
Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion as Therapy to Patients With an Infection in the Intensive Care Unit (ICU)
NCT number | NCT02993575 |
Other study ID # | UMCN-AKF-16.08 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | April 1, 2018 |
Verified date | October 2018 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared
to non-ICU patients. The investigators will determine total and free flucloxacillin
concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion
(n=20) of flucloxacillin as standard care.
Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing
regimen and limited sampling will be taken for individual patients on the continuous dosing
regimen on day 2 and 4.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient is admitted to an ICU 2. Subject is at least 18 years old on the day of the first dosing 3. Is managed with a central venous catheter or arterial line 4. Patient is treated with flucloxacillin Exclusion Criteria: 1. Has previously participated in this trial |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Medical Center | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Canisius-Wilhelmina Hospital, Gelderse Vallei Hospital, Rijnstate Hospital, Tergooi Hospital, UMC Utrecht |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clearance | Full pharmacokinetic curves will be taken on Day 2 and Day 4 | Day 2 and 4 |
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