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

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
IV and enteral administration of moxifloxacin
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV and enteral administration of moxifloxacin

Arm Description

IV and enteral administration of moxifloxacin

Outcomes

Primary Outcome Measures

Pharmacokinetics
Pharmacokinetics will be followed.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2007
Last Updated
December 7, 2012
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00458900
Brief Title
Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
Official Title
Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV and enteral administration of moxifloxacin
Arm Type
Experimental
Arm Description
IV and enteral administration of moxifloxacin
Intervention Type
Drug
Intervention Name(s)
IV and enteral administration of moxifloxacin
Intervention Description
IV and enteral administration of moxifloxacin
Primary Outcome Measure Information:
Title
Pharmacokinetics
Description
Pharmacokinetics will be followed.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Colpaert, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent

Learn more about this trial

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

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