Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection. (MOXI)

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

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.

Study Overview

• Status: Completed
• Conditions: Side-effect of Antibiotic
• Intervention / Treatment: Drug: Moxifloxacin 400 mg

Detailed Description

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
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Homburg/Saar, Germany, 66421
    • University Hospital of the Saarland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Saarland
• Collaborators: Bayer
• Investigators: Principal Investigator: Martin K Schilling, MD, University Hospital of the Saarland

Publications and helpful links

General Publications

• Weinrich M, Scheingraber S, Stremovskaia T, Schilling MK, Kees F, Pistorius GA. Liver tissue concentrations of levofloxacin after single intravenous administration of 500 mg for antibiotic prophylaxis in liver surgery. Int J Antimicrob Agents. 2006 Sep;28(3):221-5. doi: 10.1016/j.ijantimicag.2006.04.012. Epub 2006 Aug 14.
• Justinger C, Schilling MK, Kees MG, Kauffels A, Hirschmann K, Kopp B, Kees F, Kollmar O. Penetration of moxifloxacin into liver tissue. Int J Antimicrob Agents. 2012 Jun;39(6):505-9. doi: 10.1016/j.ijantimicag.2012.01.022. Epub 2012 Apr 21.

Helpful Links

• PI´s institute homepage

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 17, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics; liver resection
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: 24/06; 2008-001902-18 (EudraCT Number)