Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT01560832
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2012-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2012-03-02', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients', 'timeFrame': 'every 5 days after consented to enroll the exam', 'description': 'A laboratory-confirmed CDI case is defined as a patient who has experienced the passage of 3 or more unformed or loose stools \\[diarrhea\\] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. A hospital onset case is defined as a patient with diarrhea more than 48 hours after admission to a hospital.\n\nThe study period is the study duration, which is defined as the first date of surveillance at each hospital until the sample collection date of the last CDI positive patient (N=100).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile Infection']}, 'referencesModule': {'references': [{'pmid': '3942469', 'type': 'BACKGROUND', 'citation': 'Gerding DN, Olson MM, Peterson LR, Teasley DG, Gebhard RL, Schwartz ML, Lee JT Jr. Clostridium difficile-associated diarrhea and colitis in adults. A prospective case-controlled epidemiologic study. Arch Intern Med. 1986 Jan;146(1):95-100.'}, {'pmid': '8147353', 'type': 'BACKGROUND', 'citation': 'Anand A, Bashey B, Mir T, Glatt AE. Epidemiology, clinical manifestations, and outcome of Clostridium difficile-associated diarrhea. Am J Gastroenterol. 1994 Apr;89(4):519-23.'}, {'pmid': '8086574', 'type': 'BACKGROUND', 'citation': 'Bartlett JG. Clostridium difficile: history of its role as an enteric pathogen and the current state of knowledge about the organism. Clin Infect Dis. 1994 May;18 Suppl 4:S265-72. doi: 10.1093/clinids/18.supplement_4.s265.'}, {'pmid': '17265394', 'type': 'BACKGROUND', 'citation': 'McDonald LC, Coignard B, Dubberke E, Song X, Horan T, Kutty PK; Ad Hoc Clostridium difficile Surveillance Working Group. Recommendations for surveillance of Clostridium difficile-associated disease. Infect Control Hosp Epidemiol. 2007 Feb;28(2):140-5. doi: 10.1086/511798. Epub 2007 Jan 25.'}, {'pmid': '17599306', 'type': 'BACKGROUND', 'citation': 'Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007 Aug 1;45(3):302-7. doi: 10.1086/519265. Epub 2007 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient who has experienced the passage of 3 or more unformed or loose stools \\[diarrhea\\] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, aged ≥ 20 years at the time of hospitalization in specified wards\n* PCR-diagnosed CDI while at the hospital\n* Informed consent has been obtained from patients as required by local requirements\n\nExclusion Criteria:\n\n* Age \\< 20 years'}, 'identificationModule': {'nctId': 'NCT01560832', 'briefTitle': 'Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2011-0382'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laboratory (PCR)-confirmed C.difficile infection', 'description': 'patient who has experienced the passage of 3 or more unformed or loose stools \\[diarrhea\\] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}