Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-28 @ 11:05 PM
Study NCT ID:
NCT00760032
Status:
WITHDRAWN
Last Update Posted:
2012-12-05
First Post:
2008-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D001201', 'term': 'Ascites'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'was not possible to measure LBP levels because we cannot found the kit', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2008-09-24', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipopolysaccharide binding protein plasma levels', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Severe infection', 'timeFrame': '24 weeks'}, {'measure': 'Pro- and anti-inflammatory cytokine secretion by PBMN cells', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cirrhosis', 'Ascites', 'Lipopolysaccharide binding protein', 'Infections', 'Cytokines', 'Ciprofloxacin'], 'conditions': ['Cirrhosis', 'Ascites', 'Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.innsz.mx', 'label': "Sponsor's Web site"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis\n* Ascites\n* No history of spontaneous bacterial peritonitis and/or \\< 1 g of protein in ascites\n* No antibiotic use in previous 6 weeks\n* Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)\n* Absence of GI bleeding or encephalopathy\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Ciprofloxacin contraindication\n* Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease\n* \\> 13 Child-Pugh points\n* Inability to attend to regular visits\n* Current alcohol intake\n* Terminal disease with \\< 24 week expected survival'}, 'identificationModule': {'nctId': 'NCT00760032', 'briefTitle': 'Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'GAS-149-07-09-1'}, 'secondaryIdInfos': [{'id': 'REF. 1612'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Ciprofloxacin', 'interventionNames': ['Drug: Ciprofloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ciprofloxacin', 'type': 'DRUG', 'otherNames': ['Ciproflox'], 'description': 'Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules, one capsule per day during four weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'México', 'state': 'D.f.', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'overallOfficials': [{'name': 'Florencia Vargas-Vorackova, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florencia Vargas-Vorackova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratorios Senosiain, S.A. de C.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Florencia Vargas-Vorackova', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}