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


Phase 4
18 Years
80 Years
Not Enrolling
Both
Side-effect of Antibiotic

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Trial Information

Study on Pharmacokinetics of Moxifloxacin 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Concentration (mg/L) of moxifloxacin in liver tissue

Outcome Description:

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..

Outcome Time Frame:

1.5 hours after moxifloxacin infusion

Safety Issue:

No

Principal Investigator

Martin K Schilling, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University hospital of the Saarland

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

24/06

NCT ID:

NCT01302951

Start Date:

July 2008

Completion Date:

July 2010

Related Keywords:

  • Side-effect of Antibiotic
  • pharmacokinetics
  • liver resection

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