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

This study is currently recruiting participants.

Verified July 2011 by University Hospital, Ghent

First Received on April 10, 2007. Last Updated on July 6, 2011 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:	Allocation: Non-Randomized 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:

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

Estimated Enrollment:	4
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

IV and enteral administration of moxifloxacin

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:	Kirsten Colpaert, University Hospital Ghent
ClinicalTrials.gov Identifier:	NCT00458900 History of Changes
Other Study ID Numbers:	2007/071
Study First Received:	April 10, 2007
Last Updated:	July 6, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012