Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-02 @ 10:04 AM
Study NCT ID:
NCT03245632
Status:
UNKNOWN
Last Update Posted:
2017-08-10
First Post:
2017-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2017-08-06', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRKP infection', 'timeFrame': '7 days', 'description': 'Culture postitive results confirmed the infection of CRKP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Klebsiella Pneumoniae Infection']}, 'descriptionModule': {'briefSummary': 'Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, and the rationality of the current therapy for the CRKP infection.', 'detailedDescription': 'All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients admitted to all study hospitals and met the aboved eligibility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new confirmed noscomial infection of CRKP\n\nExclusion Criteria:\n\n* Age\\<18, or \\>85 years old; Mixed infection of CRKP and other microbes'}, 'identificationModule': {'nctId': 'NCT03245632', 'briefTitle': 'Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China', 'orgStudyIdInfo': {'id': 'SRRSH-CRKP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carbapenem-Resistant K. pneumoniae', 'description': 'Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.', 'interventionNames': ['Other: Carbapenem-Resistant Klebsiella pneumoniae']}, {'label': 'Carbapenem-Sensitive K. pneumoniae', 'description': 'Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.'}], 'interventions': [{'name': 'Carbapenem-Resistant Klebsiella pneumoniae', 'type': 'OTHER', 'description': 'no intervention, this is an obervational study.', 'armGroupLabels': ['Carbapenem-Resistant K. pneumoniae']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ying-zhi FANG, Master', 'role': 'CONTACT', 'email': 'fyz4817@126.com', 'phone': '+86 57186006811'}], 'overallOfficials': [{'name': 'Yun-song YU, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'For the time, we are not yet make determined to take the IPD plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Jian-cang Zhou M.D.', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}