Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
December 7, 2012 updated by: University Hospital, Ghent
In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations.
As moxifloxacin is known to have a high oral bioavailability in healthy volunteers, patients are switched to oral or enteral therapy as soon as possible.
However, no data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are available.
Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their inter-individual variability during IV to enteral switch therapy in IC-patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IC patients treated with 400 mg moxifloxacin IV (once a day) that can be switched to enteral administration of 400 mg moxifloxacin.
- IV steady state
- Hemodynamic stability
- Normal enteral feeding without prokinetics
- Presence of arterial line
- Informed consent
- ≥ 18 jaar
Exclusion Criteria:
- Dialysis patients
- Creatinine clearance < 30 ml/min
- Transaminase levels > 5x upper limit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: IV and enteral administration of moxifloxacin
|
IV and enteral administration of moxifloxacin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics
Time Frame: 2 days
|
Pharmacokinetics will be followed.
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (ACTUAL)
September 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
April 10, 2007
First Submitted That Met QC Criteria
April 10, 2007
First Posted (ESTIMATE)
April 11, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
December 10, 2012
Last Update Submitted That Met QC Criteria
December 7, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007/071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.