Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT01585532
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2012-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alere Mycobacterium Tuberculosis Urine Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'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': 'Urine Sputum Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity', 'timeFrame': 'On admission to hospital', 'description': 'ROC analysis to determine the best specificity and sensitivity to differentiate between patients with tuberculosis and patients with an alternative diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Urine', 'Nucleic acid', 'Alere', 'Borstel'], 'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': 'Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected or confirmed tuberculosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected or confirmed tuberculosis\n* Age \\>18 years\n* informed consent obtained\n\nExclusion Criteria:\n\n* Previous participation in the study\n* Simultaneous participation in a clinical trial investigating a new drug\n* Inability to give consent\n* Member of a vulnerable study population'}, 'identificationModule': {'nctId': 'NCT01585532', 'briefTitle': 'Alere Mycobacterium Tuberculosis Urine Study', 'organization': {'class': 'OTHER', 'fullName': 'Research Center Borstel'}, 'officialTitle': 'Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid', 'orgStudyIdInfo': {'id': 'RCBorstel002'}, 'secondaryIdInfos': [{'id': 'CLDG-0402', 'type': 'OTHER', 'domain': 'Alere Technologies GmbH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'TB suspects with alternative final diagnosis'}, {'label': 'Confirmed tuberculosis patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23845', 'city': 'Borstel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Research Center Borstel', 'geoPoint': {'lat': 53.81586, 'lon': 10.20407}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Center Borstel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alere Technologies GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}