Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: April 10, 2007
Last updated: December 7, 2012
Last verified: December 2012
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.

Condition Intervention Phase
Drug: IV and enteral administration of moxifloxacin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Pharmacokinetics will be followed.

Enrollment: 4
Study Start Date: July 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV and enteral administration of moxifloxacin
IV and enteral administration of moxifloxacin
Drug: IV and enteral administration of moxifloxacin
IV and enteral administration of moxifloxacin


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00458900

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Kirsten Colpaert, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent Identifier: NCT00458900     History of Changes
Other Study ID Numbers: 2007/071 
Study First Received: April 10, 2007
Last Updated: December 7, 2012
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

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