Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-28 @ 8:40 PM
Study NCT ID:
NCT04567134
Status:
UNKNOWN
Last Update Posted:
2020-09-28
First Post:
2020-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'C. difficile isolates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of CDI', 'timeFrame': 'through Oct 2020 to Dec 2021', 'description': 'Incidence of CDI among hospitalized adults per 100,000 patient\\*days/10,000 patient\\*admission in enrolled tertiary hospitals.'}], 'secondaryOutcomes': [{'measure': 'mortality rate', 'timeFrame': 'through Oct 2020 to May 2022', 'description': 'Proportion of CDI cases who died during the 60-day follow-up period'}, {'measure': 'recurrence rate', 'timeFrame': 'through Oct 2020 to May 2022', 'description': 'Proportion of CDI cases with recurrence/reinfection between Day 14 and Day 60'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clostridium difficile', 'incidence'], 'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who admitted at the tertiary hospitals in Korea and and diagnosed as Clostridioides difficile infection will be selected.\n\nThe tertiary hospitals located in Seoul-si, Gyeonggi-do, Pusan-si, Daegu-si, Jeollanam-do, Jeollabuk-do, and Chungcheongbuk-do. These hospitals distributes all over the country.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged older than 19 years\n* more than 3 times of unformed stools passage per day\n* positive results of toxin gene test: GDH (+) + PCR (+), GDH (+) + toxin (+), or PCR (+) + toxin (+)\n* agree with informed consent\n\nExclusion Criteria:\n\n* less than 3 times of unformed stool passage per day\n* use of oral metronidazole or vancomycin more than 24 hours before enrollment\n* use of laxative before enrollment\n* recurrent episode of CDI\n* disagree with study protocol'}, 'identificationModule': {'nctId': 'NCT04567134', 'briefTitle': 'Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University Seoul Hospital'}, 'officialTitle': 'Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea', 'orgStudyIdInfo': {'id': 'HYUH 2020-06-046'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hyunjoo Pai, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'paihyunjoo@gmail.com', 'phone': '+82-2-2290-8356'}, {'name': 'Jieun Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'quidam76@hanyang.ac.kr', 'phone': '+82-31-560-2249'}], 'overallOfficials': [{'name': 'Hyunjoo Pai, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hanyang University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University Seoul Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}