Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.

Phase 4

Completed

• Conditions: Side-effect of Antibiotic
• Interventions: Drug: Moxifloxacin 400 mg

• Registration Number: NCT01302951
• Lead Sponsor: University Hospital, Saarland

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.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2011-01-17
• Status Verified: 2011-02
• Study First Submitted QC: 2011-02-23
• Last Update Submitted: 2011-02-23
• Study First Posted: 2011-02-24
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin 400 mg	Moxifloxacin 400 mg i.v.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University hospital of the Saarland; 🇩🇪 Homburg/Saar, Germany