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

Information source: University Hospital, Saarland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Side-effect of Antibiotic

Intervention: Moxifloxacin 400 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Saarland

Official(s) and/or principal investigator(s):
Martin K Schilling, MD, Principal Investigator, Affiliation: University hospital of the Saarland

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.

Clinical Details

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

Primary outcome: Concentration (mg/L) of moxifloxacin in liver tissue

Secondary outcome:

Maximum concentration (mg/L) of moxifloxacin in serum

Number of participants with adverse events

Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

University hospital of the Saarland, Homburg/Saar 66421, Germany
Additional Information

PI´s institute homepage

Related publications:

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.

Starting date: July 2008
Last updated: February 23, 2011

Page last updated: August 23, 2015

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