Bacterial InfectionsFANATICNCT02993575
Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion to ICU Patients
An observational study of Bacterial Infections, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Flucloxacillin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2017to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving flucloxacillin for treating a suspected or proven bacterial infection at the ICU will be included.
Who may be able to join
- Patient is admitted to an ICU
- Subject is at least 18 years old on the day of the first dosing
- Is managed with a central venous catheter or arterial line
- Patient is treated with flucloxacillin
Who cannot join
- 1. Has previously participated in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion as Therapy to Patients With an Infection in the Intensive Care Unit (ICU)
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.
Read the detailed description
The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared to non-ICU patients. There is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU. To prevent the risk of inadequate dosing in critically ill patients, it is important to optimize dosing regimens in ICU patients.
With this study the investigators will define pharmacokinetics of flucloxacillin in ICU patients and search for variables influencing pharmacokinetics. By using population modeling the investigators will simulate different dosing regimens, intermittent and continuous, and compare probability of target attainment between continuous and intermittent infusion.
To be able to include 30 patients within the study duration, a multi-centre approach is necessary.
Patients will receive standard care, as stated in the product characteristics or according to local protocols. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter or an arterial line. 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.
- Conditions
- Bacterial Infections
- Being tested
- Flucloxacillin
- Keywords
- Pharmacokinetics, Flucloxacillin, Continuous infusion, Intensive Care Unit
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucloxacillinDrug
Also called Floxapen
Dose according to summary of product characteristics (SPC) or local protocols: intermittent and continuous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance
Full pharmacokinetic curves will be taken on Day 2 and Day 4
Measured: Day 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start1 Jun 2017
- Primary completion1 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Rijnstate Hospital, UMC Utrecht, Tergooi Hospital, Gelderse Vallei Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993575
- Sponsor's protocol ID
- UMCN-AKF-16.08
- Acronym
- FANATIC
- Status last verified
- Oct 2018
- First submitted
- 12 Dec 2016
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion as Therapy to Patients With an Infection in the Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT02993575
- Acronym / sponsor ID
- FANATIC / UMCN-AKF-16.08
- Conditions
- Bacterial Infections
- Keywords
- Pharmacokinetics, Flucloxacillin, Continuous infusion, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Rijnstate Hospital, UMC Utrecht, Tergooi Hospital, Gelderse Vallei Hospital
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared to non-ICU patients. There is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU. To prevent the risk of inadequate dosing in critically ill patients, it is important to optimize dosing regimens in ICU patients.
With this study the investigators will define pharmacokinetics of flucloxacillin in ICU patients and search for variables influencing pharmacokinetics. By using population modeling the investigators will simulate different dosing regimens, intermittent and continuous, and compare probability of target attainment between continuous and intermittent infusion.
To be able to include 30 patients within the study duration, a multi-centre approach is necessary.
Patients will receive standard care, as stated in the product characteristics or according to local protocols. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter or an arterial line. 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving flucloxacillin for treating a suspected or proven bacterial infection at the ICU will be included.
Key inclusion criteria (4 listed)
- Patient is admitted to an ICU
- Subject is at least 18 years old on the day of the first dosing
- Is managed with a central venous catheter or arterial line
- Patient is treated with flucloxacillin
Key exclusion criteria (1 listed)
- 1. Has previously participated in this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlucloxacillinAlso: FloxapenDose according to summary of product characteristics (SPC) or local protocols: intermittent and continuous infusion | Drug | – |
Primary outcome
Clearance
Time frame: Day 2 and 4
Full pharmacokinetic curves will be taken on Day 2 and Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance (time frame: Day 2 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.