Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-03 @ 10:48 AM
Study NCT ID:
NCT00511212
Status:
WITHDRAWN
Last Update Posted:
2011-07-21
First Post:
2007-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'No eligible patient.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2007-08-01', 'studyFirstSubmitQcDate': '2007-08-02', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical efficacy', 'timeFrame': 'at day 7'}], 'secondaryOutcomes': [{'measure': 'clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms', 'timeFrame': 'at day 3 and at the end of test drug administration,'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe peritonitis', 'SSI', 'lower digestive tract surgery', 'Severe peritonitis after lower digestive tract surgery'], 'conditions': ['Peritonitis', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.\n\n1. Patients with \\>=38 degrees C, \\>=15,000/mm3 or \\<=3,000/mm3 of WBC and \\>=10mg/dL of CRP\n2. Patients who have no abscess on the abdominal image\n3. Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement\n4. Patients who are 20 years old or older\n5. Patients who have signed the agreement for participation in this study\n\nExclusion Criteria:\n\n1. Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products\n2. Patients who have a history of shock due to any of the ingredients of Immunoglobulin products\n3. Patients who were administered immunoglobulin within 1 month before entry\n4. Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement\n5. Patients with IgA deficiency\n6. Patients with hereditary fructose intolerance\n7. Patients with history of allergy or adverse effect for antibacterial agents\n8. Patients who have underlying or concomitant disease that may seriously affect the assessment of this study\n9. Patients who are or could be pregnant\n10. Patients who have noninfectious fever, fungal infection or viral illness\n11. Other patients who are judged to be inadequate to participate in this study by their physician'}, 'identificationModule': {'nctId': 'NCT00511212', 'briefTitle': 'Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract', 'organization': {'class': 'OTHER', 'fullName': 'Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group'}, 'officialTitle': 'Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract', 'orgStudyIdInfo': {'id': 'MCSGO-0701'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intravenous immunoglobulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'overallOfficials': [{'name': 'Morito Monden, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Multicenter Clinical Study Group of Osaka'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group', 'class': 'OTHER'}}}}