Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-04-30 @ 5:23 PM
Study NCT ID:
NCT01416506
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2011-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Acquired Pneumonia (CAP) Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-04', 'studyFirstSubmitDate': '2011-08-12', 'studyFirstSubmitQcDate': '2011-08-12', 'lastUpdatePostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In vitro Minimal Inhibitory Concentration Detection', 'timeFrame': 'Up to 27 months'}], 'secondaryOutcomes': [{'measure': 'In vitro Gene Mutation Detection', 'timeFrame': 'Up to 15 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumonia, surveillance'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'Prospective, non-interventional, multi-center study. 7 investigative centers will involved in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae isolates collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese adult (male or female) \\>/= 18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese adult (male or female) ≥18 years old\n* Outpatients or inpatients who suffer from CAP\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01416506', 'briefTitle': 'Community-Acquired Pneumonia (CAP) Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Community-Acquired Pneumonia (CAP) Mycoplasma Surveillance', 'orgStudyIdInfo': {'id': '15465'}, 'secondaryIdInfos': [{'id': 'NN1010CN', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Other: No Drug']}], 'interventions': [{'name': 'No Drug', 'type': 'OTHER', 'description': "It's a surveillance", 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'China'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}