Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection. (MOXI)
This study has been completed.
Sponsor:
University Hospital, Saarland
Collaborator:
Bayer
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01302951
First received: January 17, 2011
Last updated: February 23, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Side-effect of Antibiotic |
Drug: Moxifloxacin 400 mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Saarland:
Primary Outcome Measures:
- Concentration (mg/L) of moxifloxacin in liver tissue [ Time Frame: 1.5 hours after moxifloxacin infusion ] [ Designated as safety issue: No ]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:
- Maximum concentration (mg/L) of moxifloxacin in serum [ Time Frame: at the end of intravenous infusion ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 34 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Moxifloxacin
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
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302951
Locations
| Germany | |
| University hospital of the Saarland | |
| Homburg/Saar, Germany, 66421 | |
Sponsors and Collaborators
University Hospital, Saarland
Bayer
Investigators
| Principal Investigator: | Martin K Schilling, MD | University hospital of the Saarland |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Martin K Schilling MD, FRCS, University of the Saarland |
| ClinicalTrials.gov Identifier: | NCT01302951 History of Changes |
| Other Study ID Numbers: | 24/06, 2008-001902-18 |
| Study First Received: | January 17, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital, Saarland:
|
pharmacokinetics liver resection |
Additional relevant MeSH terms:
|
Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined |
Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013