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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

Page last updated: August 23, 2015

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