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

University Hospital, Saarland34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Side-effect of Antibiotic

Interventions

Moxifloxacin 400 mgDRUG

The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University hospital of the Saarland

Homburg/Saar, Germany

Outcomes

Primary Outcomes

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..

Time frame: 1.5 hours after moxifloxacin infusion

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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