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

NCT01302951 | Completed Phase 4

• 2 other identifiers: 24/062008-001902-18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Side-effect of Antibiotic

Keywords

pharmacokinetics; liver resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum concentration (mg/L) of moxifloxacin in serum

  at the end of intravenous infusion

• Number of participants with adverse events

  48 hours

• Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L)

  48 hours

Study Arms (2)

Moxifloxacin

EXPERIMENTAL

Moxifloxacin 400 mg i.v.

Drug: Moxifloxacin 400 mg

No drug

NO INTERVENTION

2 Patients were included as controls- no MXF given

Interventions

Moxifloxacin 400 mg DRUG

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

Also known as: Avalox 400mg/250ml

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• subjects with contra-indications to Moxifloxacin
• subjects under therapy with Moxifloxacin within 2 weeks before recruitment

Sponsors & Collaborators

• University Hospital, Saarland: lead
• Bayer: collaborator

Study Sites (1)

University hospital of the Saarland

Homburg/Saar, 66421, Germany

Location

Related Publications (2)

• 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.

  PMID: 16904875 BACKGROUND

• 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.

  PMID: 22526014 DERIVED

Related Links

• PI´s institute homepage

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Martin K Schilling, MD

  University hospital of the Saarland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: February 24, 2011
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 24, 2011

Record last verified: 2011-02

Locations

DE (1)