Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00384527
Status:
TERMINATED
Last Update Posted:
2015-05-05
First Post:
2006-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Study was terminated early due to slow recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2006-10-05', 'studyFirstSubmitQcDate': '2006-10-05', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response (resolution of all symptoms of CDAD)', 'timeFrame': 'End of treatment (day 12-14 after beginning treatment)'}], 'secondaryOutcomes': [{'measure': 'Time from first dose to resolution of symptoms of CDAD', 'timeFrame': 'Any time after beginning treatment and must be sustained through end of treatment visit'}, {'measure': 'Microbiological Recurrence', 'timeFrame': 'Clinical response at end of treatment visit with recurrence of symtpoms prior to study day 31 and C. difficile toxins detected in stool.'}, {'measure': 'Sustained clinical response', 'timeFrame': 'End of treatment response sustained through study day 31.'}, {'measure': 'Clinical Recurrence', 'timeFrame': 'Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clostridium difficile'], 'conditions': ['Clostridium Infections']}, 'referencesModule': {'references': [{'pmid': '19133801', 'type': 'DERIVED', 'citation': 'Musher DM, Logan N, Bressler AM, Johnson DP, Rossignol JF. Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study. Clin Infect Dis. 2009 Feb 15;48(4):e41-6. doi: 10.1086/596552.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within 24 hours), and one or more of the following symptoms of CDAD:\n\n * abdominal pain or cramps\n * peripheral leukocytosis\n * fever\n* C. difficile toxin A or B detected in a stool specimen obtained within 3 days before enrollment by enzyme immunoassay.\n* Patients willing to avoid the following medications during the study:\n\n * oral and intravenous metronidazole\n * oral vancomycin\n * anti-peristaltic drugs\n * opiates (patients on opiates may be included in the study if they were taking opiates prior to enrollment and the dose is not increased during the study)\n * Saccharomyces cerevisiae (baker's yeast)\n * Lactobacillus GG\n * cholestyramine\n * colestipol\n\nExclusion Criteria:\n\n* Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella, Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy).\n* Patients that commonly have 3 or more stools per day and/or severe abdominal pain in the absence of CDAD.\n* Patients with severe lactose intolerance.\n* Patients with more than 1 recurrence of CDAD during the 6 months prior to enrollment.\n* Patients unable to take oral medications.\n* Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity such as oral or intravenous metronidazole and oral vancomycin. \\[Patients that have taken up to 3 doses of metronidazole or vancomycin can be included in the study\\].\n* Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.\n* Patients who are either clinically unstable (e.g., fulminant disease patients with signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to live throughout the 31-day duration of the study due to underlying illness.\n* History of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in the formulations."}, 'identificationModule': {'nctId': 'NCT00384527', 'briefTitle': 'Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Romark Laboratories L.C.'}, 'officialTitle': 'Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease', 'orgStudyIdInfo': {'id': 'RM01-3032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Nitazoxanide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'otherNames': ['Alinia'], 'description': 'One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.', 'armGroupLabels': ['1']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['VANCOCIN'], 'description': 'One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Hospital', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33744', 'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Pines VAMC', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'zip': '30030', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Institute for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar Clinical Trials', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Richard L. Roudebush VAMC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '76121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Oschner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'John D. Dingell VAMC', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Center for Digestive Health', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. Debakey VAMC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Carol Kauffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'John D. Dingell VAMC'}, {'name': 'Adam Bressler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta Institute for Medical Research'}, {'name': 'Wesley Bray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wellstar Clinical Trials'}, {'name': 'James Grendell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winthrop University Hospital'}, {'name': 'Bradley Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Richard L. Roudebush VA Medical Center'}, {'name': 'Partha Nandi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Digestive Health'}, {'name': 'Daniel Musher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. Debakey VAMC'}, {'name': 'Julia Garcia-Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oschner Clinic Foundation'}, {'name': 'David Rand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Torrence Memorial Hospital'}, {'name': 'David Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bay Pines VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Romark Laboratories L.C.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Romark Laboratories, L.C.', 'oldOrganization': 'Romark Laboratories, L.C.'}}}}