Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01302951
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2011-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-23', 'studyFirstSubmitDate': '2011-01-17', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration (mg/L) of moxifloxacin in liver tissue', 'timeFrame': '1.5 hours after moxifloxacin infusion', 'description': '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..'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (mg/L) of moxifloxacin in serum', 'timeFrame': 'at the end of intravenous infusion', 'description': '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.'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '48 hours', 'description': 'The number of participants and kind of adverse events were recorded up to 48 hours after intravenous infusion of 400 mg moxifloxacin.'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L)', 'timeFrame': '48 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'liver resection'], 'conditions': ['Side-effect of Antibiotic']}, 'referencesModule': {'references': [{'pmid': '16904875', 'type': 'BACKGROUND', '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.'}, {'pmid': '22526014', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.uniklinikum-saarland.de/de/einrichtungen/kliniken_institute/chirurgie/allgemeinchirurgie/', 'label': 'PI´s institute homepage'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-80 years old\n* elective liver resection of liver tumor\n* in females: pregnancy test negative\n* Subjects willing and able to give fully informed written consent\n\nExclusion Criteria:\n\n* subjects with contra-indications to Moxifloxacin\n* subjects under therapy with Moxifloxacin within 2 weeks before recruitment'}, 'identificationModule': {'nctId': 'NCT01302951', 'acronym': 'MOXI', 'briefTitle': 'Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'Study on Pharmacokinetics of Moxifloxacin in Serum and Liver Tissue of Patients Undergoing Liver Resection Due to Primary or Secondary Tumor of the Liver', 'orgStudyIdInfo': {'id': '24/06'}, 'secondaryIdInfos': [{'id': '2008-001902-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moxifloxacin', 'description': 'Moxifloxacin 400 mg i.v.', 'interventionNames': ['Drug: Moxifloxacin 400 mg']}, {'type': 'NO_INTERVENTION', 'label': 'No drug', 'description': '2 Patients were included as controls- no MXF given'}], 'interventions': [{'name': 'Moxifloxacin 400 mg', 'type': 'DRUG', 'otherNames': ['Avalox 400mg/250ml'], 'description': 'The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.', 'armGroupLabels': ['Moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'University hospital of the Saarland'}], 'overallOfficials': [{'name': 'Martin K Schilling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of the Saarland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Martin K Schilling MD, FRCS', 'oldOrganization': 'University of the Saarland'}}}}