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
  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 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
Pneumonia
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014