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

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ClinicalTrials.gov Identifier: NCT01302951
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Collaborator:
Bayer
Information provided by:
University Hospital, Saarland

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.

Condition or disease Intervention/treatment Phase
Side-effect of Antibiotic Drug: Moxifloxacin 400 mg Phase 4

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  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study on Pharmacokinetics of Moxifloxacin in Serum and Liver Tissue of Patients Undergoing Liver Resection Due to Primary or Secondary Tumor of the Liver
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Avalox 400mg/250ml
No Intervention: No drug
2 Patients were included as controls- no MXF given



Primary Outcome Measures :
  1. Concentration (mg/L) of moxifloxacin in liver tissue [ Time Frame: 1.5 hours after moxifloxacin infusion ]
    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..


Secondary Outcome Measures :
  1. Maximum concentration (mg/L) of moxifloxacin in serum [ Time Frame: at the end of intravenous infusion ]
    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.

  2. Number of participants with adverse events [ Time Frame: 48 hours ]
    The number of participants and kind of adverse events were recorded up to 48 hours after intravenous infusion of 400 mg moxifloxacin.

  3. Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L) [ Time Frame: 48 hours ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302951


Locations
Germany
University hospital of the Saarland
Homburg/Saar, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Bayer
Investigators
Principal Investigator: Martin K Schilling, MD University hospital of the Saarland

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin K Schilling MD, FRCS, University of the Saarland
ClinicalTrials.gov Identifier: NCT01302951     History of Changes
Other Study ID Numbers: 24/06
2008-001902-18 ( EudraCT Number )
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011

Keywords provided by University Hospital, Saarland:
pharmacokinetics
liver resection

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors