Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection. (MOXI)
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.
|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|
- 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..
- 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.
|Study Start Date:||July 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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
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.
|University hospital of the Saarland|
|Homburg/Saar, Germany, 66421|
|Principal Investigator:||Martin K Schilling, MD||University hospital of the Saarland|