Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-02-24 @ 4:16 AM
Study NCT ID:
NCT00917592
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004238', 'term': 'Diverticulitis'}], 'ancestors': [{'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'failure of treatment', 'timeFrame': 'the 4th day (group 1) or the 8th day (group 2)'}], 'secondaryOutcomes': [{'measure': 'emergency admission or hospital readmission for reasons related to the previous diverticulitis', 'timeFrame': '30 days after discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diverticulitis'], 'conditions': ['Diverticulitis']}, 'descriptionModule': {'briefSummary': "Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an enormous diversity in clinical practice. The investigators' aim was to demonstrate that uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a short hospital admission.", 'detailedDescription': 'A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment" which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours\n\nExclusion Criteria (prerandomization):\n\n* immunocompromised patients\n* pregnant women\n* clinical suspicion or CT confirmation of complicated acute diverticulitis\n* Karnofsky performance score less than 50%\n* allergy to penicillin\n\nExclusion Criteria (postrandomization):\n\n* withdrawal of the trial\n* CT confirmation of complicated acute diverticulitis\n* CT not conforming to acute diverticulitis\n* CT performed 72 hours after the admission\n* adverse reaction to the antibiotic\n* bacteriemia'}, 'identificationModule': {'nctId': 'NCT00917592', 'acronym': 'DANC-05', 'briefTitle': 'Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Prospective Randomized Clinical Trial Assessing the Efficacy of a Short Course of Intravenous Amoxicillin Plus Clavulanic Acid Followed by Oral Antibiotic in Patients With Uncomplicated Acute Diverticulitis', 'orgStudyIdInfo': {'id': 'DANC-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short intravenous amoxicillin plus clavulanic acid', 'description': 'Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days', 'interventionNames': ['Drug: amoxicillin plus clavulanic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long intravenous amoxicillin plus clavulanic acid', 'description': 'Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days', 'interventionNames': ['Drug: amoxicillin plus clavulanic acid']}], 'interventions': [{'name': 'amoxicillin plus clavulanic acid', 'type': 'DRUG', 'description': 'intravenous amoxicillin plus clavulanic acid 1 gr every 8 hours 48 hours followed by oral amoxicillin plus clavulanic acid 1 gr every 8 hours for 10 days', 'armGroupLabels': ['Long intravenous amoxicillin plus clavulanic acid', 'Short intravenous amoxicillin plus clavulanic acid']}, {'name': 'amoxicillin plus clavulanic acid', 'type': 'DRUG', 'description': 'intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days', 'armGroupLabels': ['Long intravenous amoxicillin plus clavulanic acid', 'Short intravenous amoxicillin plus clavulanic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Yolanda Ribas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorci Sanitari de Terrassa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yolanda Ribas', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}