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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00458900
First received: April 10, 2007
Last updated: December 7, 2012
Last verified: December 2012

April 10, 2007
December 7, 2012
July 2007
September 2012   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics will be followed.
Pharmacokinetics
Complete list of historical versions of study NCT00458900 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pneumonia
Drug: IV and enteral administration of moxifloxacin
IV and enteral administration of moxifloxacin
Experimental: IV and enteral administration of moxifloxacin
IV and enteral administration of moxifloxacin
Intervention: Drug: IV and enteral administration of moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00458900
2007/071
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Kirsten Colpaert, MD University Hospital, Ghent
University Hospital, Ghent
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP