Side-effect of Antibiotic
Conditions
Keywords
pharmacokinetics, liver resection
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.
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.
Interventions
DRUGMoxifloxacin 400 mg
The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.
Sponsors
Bayer
University Hospital, Saarland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration (mg/L) of moxifloxacin in liver tissue | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (mg/L) of moxifloxacin in serum | 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. |
| Number of participants with adverse events | 48 hours | 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) | 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. |
Countries
Germany
Outcome results
None listed