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

Side-effect of Antibiotic Clinical Trial

— MOXI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302951
• Other study ID #: 24/06
• Secondary ID: 2008-001902-18
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2011
• Last updated: February 23, 2011
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2011
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Side-effect of Antibiotic

Intervention

Drug:
• Moxifloxacin 400 mg
The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.

Locations

Country	Name	City	State
Germany	University hospital of the Saarland	Homburg/Saar

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Saarland	Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Weinrich M, Scheingraber S, Stremovskaia T, Schilling MK, Kees F, Pistorius GA. Liver tissue concentrations of levofloxacin after single intravenous administration of 500 mg for antibiotic prophylaxis in liver surgery. Int J Antimicrob Agents. 2006 Sep;28(3):221-5. Epub 2006 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration (mg/L) of moxifloxacin in liver tissue	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..	1.5 hours after moxifloxacin infusion	No
Secondary	Maximum concentration (mg/L) of moxifloxacin in serum	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.	at the end of intravenous infusion	No
Secondary	Number of participants with adverse events	The number of participants and kind of adverse events were recorded up to 48 hours after intravenous infusion of 400 mg moxifloxacin.	48 hours	Yes
Secondary	Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L)	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.	48 hours	No

External Links

•   PI´s institute homepage