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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, April 2009

First Received: April 10, 2007 Last Updated: April 9, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00458900

Purpose

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 plasmalevels for moxifloxacin during such a switch-therapy in IC-patients are available. Therefore, this study aims to evaluate the moxifloxacin-plasmalevels and their inter-individual variability during IV to enteral switch therapy in IC-patients.

Condition	Intervention	Phase
Pneumonia	Drug: IV and enteral administration of moxifloxacin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Pharmacokinetics

Estimated Enrollment:	12
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458900

Contacts

Contact: Koen Boussery, Pharmacist

+32 9 332.81.10

koen.boussery@UGent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Koen Boussery, Pharmacist +32 9 332.81.10 koen.boussery@UGent.be
Principal Investigator: Kirsten Colpaert, MD

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Kirsten Colpaert, MD

University Hospital, Ghent

More Information

Additional Information:

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Kirsten Colpaert )
Study ID Numbers:	2007/071
Study First Received:	April 10, 2007
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00458900 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Moxifloxacin

Therapeutic Uses
Lung Diseases
Pharmacologic Actions
Pneumonia

ClinicalTrials.gov processed this record on February 08, 2010