Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-28 @ 7:09 PM
Study NCT ID:
NCT00481702
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2007-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081206', 'term': 'Duration of Therapy'}, {'id': 'D000077727', 'term': 'Ertapenem'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2007-06-01', 'studyFirstSubmitQcDate': '2007-06-01', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection', 'timeFrame': '2 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection', 'timeFrame': '4 weeks after treatment'}]}, 'conditionsModule': {'conditions': ['Intra-abdominal Infection']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '17462256', 'type': 'BACKGROUND', 'citation': 'Navarro NS Jr, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ; Oasis II Study Team. Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. Int J Surg. 2005;3(1):25-34. doi: 10.1016/j.ijsu.2005.03.010.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients age 18 or older\n* Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain\n\nExclusion Criteria:\n\n* Patient has another infection, other than abdominal\n* Female patient is pregnant or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT00481702', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults', 'orgStudyIdInfo': {'id': '0826-802'}, 'secondaryIdInfos': [{'id': '2007_558'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks', 'type': 'DRUG'}, {'name': 'MK0826, /Duration of Treatment : 8 Weeks', 'type': 'DRUG'}, {'name': 'Comparator: metronidazole / Duration of Treatment: 8 Weeks', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}