Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection. (MOXI)
|ClinicalTrials.gov Identifier: NCT01302951|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Side-effect of Antibiotic||Drug: Moxifloxacin 400 mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||July 2008|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
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
- Concentration (mg/L) of moxifloxacin in liver tissue [ Time Frame: 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..
- Maximum concentration (mg/L) of moxifloxacin in serum [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302951
|University hospital of the Saarland|
|Homburg/Saar, Germany, 66421|
|Principal Investigator:||Martin K Schilling, MD||University hospital of the Saarland|