Clinical trial NCT01302951: Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Side-effect of Antibiotic
Keywords: pharmacokinetics
liver resection
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2011-02-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Concentration (mg/L) of moxifloxacin in liver tissue
timeFrame: 1.5 hours after moxifloxacin infusion
Secondary outcomes:
measure: Maximum concentration (mg/L) of moxifloxacin in serum
timeFrame: at the end of intravenous infusion
measure: Number of participants with adverse events
timeFrame: 48 hours
measure: Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: University hospital of the Saarland
Study officials:
affiliation: University hospital of the Saarland
name: Martin K Schilling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ijantimicag.2006.04.012. Epub 2006 Aug 14.
citation: Justinger C, Schilling MK, Kees MG, Kauffels A, Hirschmann K, Kopp B, Kees F, Kollmar O. Penetration of moxifloxacin into liver tissue. Int J Antimicrob Agents. 2012 Jun;39(6):505-9. doi: 10.1016/j.ijantimicag.2012.01.022. Epub 2012 Apr 21.