Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-31 @ 7:03 PM
Study NCT ID:
NCT01138566
Status:
UNKNOWN
Last Update Posted:
2010-06-07
First Post:
2010-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2010-06-04', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['community-onset urinary tract infections caused by Enterobacteriaceae'], 'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n1. To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)\n2. To collect the background, risk factors and clinical outcome of patients with community-acquired uropathogenic condition related to Enterobacteriaceae (both ESBL, AmpC- and non ESBL and/or AmpC producing) after receive different antibiotic regimens.\n3. To develop a scoring system to early identify patients at risk of being infected with ESBL- and/or AmpC-producing Enterobacteriaceae by comparing the risk factors for community-onset UTIs caused by ESBL- and/or AmpC-positive against non ESBL -and/or AmpC Enterobacteriaceae\n4. To demonstrate the efficacy and safety of ertapenem for the empiric treatment of community-onset UTIs in patients at risk for ESBL- and/or AmpC-producing organism.\n\nThe study hypothesis (i) Patients infected with community-acquired uropathogenic ESBL- and/or AmpC-producing Enterobacteriaceae who receive regimens other than carbapenems have a worse outcome.\n\n(ii) There are certain risk factors predicting the acquisition of community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.\n\n(iii) The use of ertapenem is an effective and safe empirical therapy compared with other agents for community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who admitted to the Taipei Veterans General Hospital, a 2900-bed tertiary-care teaching hospital located in Taipei, Taiwan, with the diagnosis of community-onset UTI caused by Enterobacteriaceae', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who admitted to the Taipei Veterans General Hospital with the diagnosis of community-onset UTI caused by Enterobacteriaceae will be eligible for inclusion in this study if hospitalization for parental antimicrobial therapy is required\n\nExclusion Criteria:\n\n* pregnancy or lactation in women,\n* history of serious allergy or intolerance to study drug therapy (patients with a history of mild rash to β-lactams could be enrolled),\n* complete obstruction of the urinary tract,\n* peri-nephritic or intrarenal abscess, prostatitis, any rapidly progressive disease or terminal illness,\n* immuno-compromising illness or immuno suppression therapy, the need for concomitant antimicrobials in addition to study therapy,\n* a baseline pathogen resistant to study drug,\n* treatment with a systemic antimicrobial agent for \\>24 h within 72 h prior to enrolment, or absolute neutrophil count \\<1000/mm3.\n* Men with a history or physical findings suggestive of acute or chronic prostatitis will also excluded.'}, 'identificationModule': {'nctId': 'NCT01138566', 'briefTitle': 'Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae', 'orgStudyIdInfo': {'id': 'IISP37925'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESBL- and/or AmpC-(+) or (-)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Vterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chang-Phone Fung, M.D.', 'role': 'CONTACT', 'email': 'cpfung@vghtpe.gov.tw', 'phone': '+886-2-2875-7494'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}]}}}