Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.

Study Overview
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Brief Summary
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The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.

Detailed Description
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After given informed consent, patients scheduled for planned liver resection are enrolled into the study. The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. Blood and healthy liver tissue are sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36 and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying a two-compartment model.

Official Title
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Study on Pharmacokinetics of Moxifloxacin in Serum and Liver Tissue of Patients Undergoing Liver Resection Due to Primary or Secondary Tumor of the Liver

Conditions
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Side-effect of Antibiotic

Intervention / Treatment
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* Drug: Moxifloxacin 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 years old elective liver resection of liver tumor in females: pregnancy test negative Subjects willing and able to give fully informed written consent Exclusion Criteria: subjects with contra-indications to Moxifloxacin subjects under therapy with Moxifloxacin within 2 weeks before recruitment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin<br>Moxifloxacin 400 mg i.v. | Drug: Moxifloxacin 400 mg<br>* The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.<br>* Other names: Avalox 400mg/250ml;|
| No Intervention: No drug<br>2 Patients were included as controls- no MXF given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration (mg/L) of moxifloxacin in liver tissue | The first outcome of this study was to analyze the concentration of MFX in liver tissue of patients who received MFX 400 mg i.v.. | 1.5 hours after moxifloxacin infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (mg/L) of moxifloxacin in serum | The maximum concentration (mg/L) of moxifloxacin in the serum of patients who received 400 mg moxifloxacin was measured at the end of the intravenous infusion. | at the end of intravenous infusion | 
| Number of participants with adverse events | The number of participants and kind of adverse events were recorded up to 48 hours after intravenous infusion of 400 mg moxifloxacin. | 48 hours | 
| Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L) | The serum concentration of moxifloxacin was measured at different time points (2, 3, 4, 6, 8, 12, 24, 36 hour after infusion) up to 48 hours after intravenous infusion of 400 mg moxifloxacin. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, liver resection