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NCT00458900 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00458900
Other study ID # 2007/071
Secondary ID
Status Completed
Phase Phase 2
First received April 10, 2007
Last updated December 7, 2012
Start date July 2007
Est. completion date September 2012

Study information
Verified date December 2012
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• IV and enteral administration of moxifloxacin
IV and enteral administration of moxifloxacin

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics Pharmacokinetics will be followed. 2 days Yes
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