Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-02 @ 1:55 PM
Study NCT ID:
NCT01857050
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reasons for INR prolongation in patients who were treated with the combination of Warfarin and Cephalosporins', 'timeFrame': 'Participants will be followed for the duration of thei hospital stay, an expected average of 7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Venous Thrombosis', 'Pulmonary Embolism', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "Many drug interactions with Warfarin are well documented in the literature, including interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict when the interaction remains theoretical and when it becomes clinically significant and will be reflected in the individual patient. This study's aim is to identify and characterize related conditions (including comorbidities, laboratory test results and other parameters related to the patient)that might be predictors for drug interactions turning from theoretical to clinically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Warfarin-treated patients who were hospitalized for any reason in the department of internal medicine and were treated with antibiotics from the Cephalosporins group during their hospitalization.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 and over\n* Patients treated with a combination of Warfarin and Cephalosporins\n* Patients who were hospitalized in the department of internal medicine\n* Patients who were treated with Warfarin without Cefalosporins\n\nExclusion Criteria:\n\n* Patients on Warfarin who did not actually receive the drug during their hospitalization\n* Patients whose medical records were not accessible or didn't contain full data"}, 'identificationModule': {'nctId': 'NCT01857050', 'briefTitle': 'Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Assessment of INR Prolongation in Patients Treated Simultaneously With Warfarin and Antibiotics From the Cephalosporins Family,Observational Retrospective Study.', 'orgStudyIdInfo': {'id': 'MMC130210-12CTIL'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Lishner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Hospital, Kfar Saba, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}