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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Pneumonia

Treatments: Drug: IV and enteral administration of moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00458900

2007/071

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

IV and enteral administration of moxifloxacin

Experimental group

Description:

IV and enteral administration of moxifloxacin

Treatment:

Drug: IV and enteral administration of moxifloxacin