Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 4:42 AM
Study NCT ID:
NCT00229060
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077726', 'term': 'Doripenem'}], 'ancestors': [{'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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 483}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-08', 'studyFirstSubmitDate': '2005-09-27', 'studyFirstSubmitQcDate': '2005-09-27', 'lastUpdatePostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The clinical response measured at late follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study.'}]}, 'conditionsModule': {'keywords': ['Complicated Intra-Abdominal Infections', 'Appendicitis', 'Cholecystitis', 'Peritonitis'], 'conditions': ['Bacterial Infections and Mycoses', 'Appendicitis', 'Cholecystitis', 'Pancreatitis', 'Peritonitis']}, 'referencesModule': {'references': [{'pmid': '20211892', 'type': 'DERIVED', 'citation': 'Kaniga K, Flamm R, Tong SY, Lee M, Friedland I, Redman R. Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies. Antimicrob Agents Chemother. 2010 May;54(5):2119-24. doi: 10.1128/AAC.01450-09. Epub 2010 Mar 8.'}, {'pmid': '19670912', 'type': 'DERIVED', 'citation': 'Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16. doi: 10.2165/00002018-200932090-00001.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=639&filename=CR005389_CSR.pdf', 'label': 'A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Meropenem in Complicated Intra-abdominal Infections (JNJ-38174942; DORI-08)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.', 'detailedDescription': 'Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. Doripenem or comparator is administered. The primary endpoint is the clinical response measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a requirement for surgical intervention within 24 hours of study entry\n* Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections\n\nExclusion Criteria:\n\n* Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control\n* Any rapidly-progressing disease or immediately life-threatening illness'}, 'identificationModule': {'nctId': 'NCT00229060', 'briefTitle': 'Doripenem in the Treatment of Complicated Intra-Abdominal Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections', 'orgStudyIdInfo': {'id': 'CR005389'}}, 'armsInterventionsModule': {'interventions': [{'name': 'doripenem', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Peninsula Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}]}}}