Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: IV and enteral administration of moxifloxacin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s):
Kirsten Colpaert, MD, Principal Investigator, Affiliation: University Hospital, Ghent
Summary
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.
Clinical Details
Official title: Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital Ghent, Ghent 9000, Belgium
Additional Information
Website University Hospital Ghent
Starting date: July 2007
Last updated: December 7, 2012
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