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

NCT ID: NCT00458900

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IV and enteral administration of moxifloxacin

IV and enteral administration of moxifloxacin

Group Type EXPERIMENTAL

IV and enteral administration of moxifloxacin

Intervention Type DRUG

IV and enteral administration of moxifloxacin

Interventions

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IV and enteral administration of moxifloxacin

IV and enteral administration of moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsten Colpaert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2007/071

Identifier Type: -

Identifier Source: org_study_id