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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01302951
First received: January 17, 2011
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Side-effect of Antibiotic
Drug: Moxifloxacin 400 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • Concentration (mg/L) of moxifloxacin in liver tissue [ Time Frame: 1.5 hours after moxifloxacin infusion ] [ Designated as safety issue: No ]
    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:
  • Maximum concentration (mg/L) of moxifloxacin in serum [ Time Frame: at the end of intravenous infusion ] [ Designated as safety issue: No ]
    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.

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

  • Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: January 17, 2011
Last Updated: February 23, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:
pharmacokinetics
liver resection

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014