Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT02327520
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204666}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-24', 'studyFirstSubmitDate': '2014-12-22', 'studyFirstSubmitQcDate': '2014-12-24', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death rate and length of hospital stay in CDI during admission', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.'}, {'measure': 'Hospital charge of CDI', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clostridium difficile infection', 'burden', 'nationwide study', 'South East Asia', 'Thailand', 'Epidemiology', 'Outcome Assessment (Health Care) [N04.761.559.590]'], 'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with the diagnosis of Clostridium difficile (ICD10-A07) with age of more than 18 years were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with the diagnosis of Clostridium difficile (ICD10-A07)\n* Age of more than 18 years.\n\nExclusion Criteria:\n\n* Data incompleted'}, 'identificationModule': {'nctId': 'NCT02327520', 'briefTitle': 'Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study', 'organization': {'class': 'OTHER', 'fullName': 'King Chulalongkorn Memorial Hospital'}, 'officialTitle': 'The Burden of Clostridium Difficile Infection in Thai Population: the First Report in Southeast Asia by 2010 Nationwide Study', 'orgStudyIdInfo': {'id': 'RP009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colitis with CDI', 'description': 'Patients who diagnosed with CDI will be analysed', 'interventionNames': ['Other: Colitis with CDI treatment']}], 'interventions': [{'name': 'Colitis with CDI treatment', 'type': 'OTHER', 'description': 'All patients will be treated with standard treatment', 'armGroupLabels': ['Colitis with CDI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rapat Pittayanon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Chulalongkorn Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Chulalongkorn Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastrointestinal Unit, King Chulalongkorn Memorial Hospital', 'investigatorFullName': 'Rapat Pittayanon, MD', 'investigatorAffiliation': 'King Chulalongkorn Memorial Hospital'}}}}