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

January 17, 2011
February 23, 2011
July 2008
July 2010   (final data collection date for primary outcome measure)
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..
Same as current
Complete list of historical versions of study NCT01302951 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Side-effect of Antibiotic
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
  • Experimental: Moxifloxacin
    Moxifloxacin 400 mg i.v.
    Intervention: Drug: Moxifloxacin 400 mg
  • No Intervention: No drug
    2 Patients were included as controls- no MXF given

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01302951
24/06, 2008-001902-18
No
Martin K Schilling MD, FRCS, University of the Saarland
University Hospital, Saarland
Bayer
Principal Investigator: Martin K Schilling, MD University hospital of the Saarland
University Hospital, Saarland
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP