Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-29 @ 4:17 AM
Study NCT ID:
NCT02968758
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2016-11-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keith.chiasson@genepoc.ca', 'phone': '418-650-3535', 'title': 'Dr Keith Chiasson, PhD', 'phoneExt': '322', 'organization': 'GenePOC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event were assessed at the time of individual patient enrollment and participation, which lasts approximately 1-2 minutes at most.', 'description': 'Adverse event procedures were established at each site, but no adverse event was observed nor reported during the enrollment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Accuracy Testing', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.', 'otherNumAtRisk': 2461, 'deathsNumAtRisk': 2461, 'otherNumAffected': 0, 'seriousNumAtRisk': 2461, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'OG000'}, {'value': '1664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accuracy Testing - Fresh Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}, {'id': 'OG001', 'title': 'Accuracy Testing - Frozen Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '99.1'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '90.8', 'upperLimit': '97.9'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '95.1'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).\n\nSensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.\n\nSpecificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.', 'unitOfMeasure': 'percentage of specimens', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive and Negative Predictive Values (PPV and NPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'OG000'}, {'value': '1664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accuracy Testing - Fresh Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}, {'id': 'OG001', 'title': 'Accuracy Testing - Frozen Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}], 'classes': [{'title': 'PPV', 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000', 'lowerLimit': '73.6', 'upperLimit': '88.6'}, {'value': '83.1', 'groupId': 'OG001', 'lowerLimit': '77.7', 'upperLimit': '87.7'}]}]}, {'title': 'NPV', 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '98.0'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.\n\nPPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).\n\nNPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).', 'unitOfMeasure': 'percentage of specimens', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unresolved Sample Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'OG000'}, {'value': '1664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accuracy Testing - Fresh Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}, {'id': 'OG001', 'title': 'Accuracy Testing - Frozen Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '2.13'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '1.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).', 'unitOfMeasure': 'percentage of Unresolved', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Indeterminate Sample Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'OG000'}, {'value': '1664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accuracy Testing - Fresh Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}, {'id': 'OG001', 'title': 'Accuracy Testing - Frozen Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '2.20'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '2.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).', 'unitOfMeasure': 'percentage of Indeterminates', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Accuracy Testing - Fresh Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}, {'id': 'FG001', 'title': 'Accuracy Testing - Frozen Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '797'}, {'groupId': 'FG001', 'numSubjects': '1664'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '797'}, {'groupId': 'FG001', 'numSubjects': '1664'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}, {'value': '1664', 'groupId': 'BG001'}, {'value': '2461', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Accuracy Testing - Fresh Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}, {'id': 'BG001', 'title': 'Accuracy Testing - Frozen Specimen', 'description': 'Comparison between GenePOC PCR and Reference Method\n\nComparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}, {'value': '1664', 'groupId': 'BG001'}, {'value': '2461', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '399', 'groupId': 'BG000'}, {'value': '800', 'groupId': 'BG001'}, {'value': '1199', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '784', 'groupId': 'BG001'}, {'value': '1148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'All Genders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Gender information was not collected during the trial.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}, {'value': '1664', 'groupId': 'BG001'}, {'value': '2461', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}, {'value': '1664', 'groupId': 'BG001'}, {'value': '2461', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '718', 'groupId': 'BG000'}, {'value': '1664', 'groupId': 'BG001'}, {'value': '2382', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'all specimens were included'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-12', 'size': 930264, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-16T08:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2461}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2016-11-15', 'resultsFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-09', 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).\n\nSensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.\n\nSpecificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative Predictive Values (PPV and NPV)', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.\n\nPPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).\n\nNPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).'}, {'measure': 'Unresolved Sample Results', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).'}, {'measure': 'Indeterminate Sample Results', 'timeFrame': 'At the time of the results with Reference Method is confirmed, up to 3 months', 'description': 'To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.', 'detailedDescription': 'The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI).\n\nThe GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which consists of:\n\n1. Transfer Loop (TL)\n2. CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)\n3. CDiff Sample Buffer Tube (SBT)\n4. Disposable Transfer Tool (DTT).\n\nThe GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.\n\nAn unformed (soft or liquid) stool specimen is collected using standard stool collection device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized stool specimen, stool material is transferred into SBT and vortexed. Sample is then transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed by the GenePOC Instrument. On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.\n\nOne GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150 specimens positive for CDiff based on the Reference Method final result.\n\nSubject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unformed Stool specimens from patients suspected of having CDI for whom diagnostic tests are indicated and ordered;\n* At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of its container);\n* Only one (1) specimen per patient will be included in the study;\n* Materials use within their expiration date;\n* Transport, storage times, and conditions (e.g. room temperature and/or refrigerated) within requested indications.\n\nExclusion Criteria:\n\n* Specimens from patients for whom CDI diagnostic tests have not been ordered;\n* Transport and storage times and conditions that exceed these Study Protocol requirements;\n* Formed or hard stool specimens or rectal swabs.'}, 'identificationModule': {'nctId': 'NCT02968758', 'briefTitle': 'Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meridian Bioscience, Inc.'}, 'officialTitle': 'Prospective Multi-Center Study for Clinical Validation of the Molecular-Based GenePOC CDiff System for the Detection of Toxin B Gene From Toxigenic Clostridium Difficile Strains in Unformed (Soft or Liquid) Human Stool Specimens', 'orgStudyIdInfo': {'id': 'GenePOC CDiff_clinical-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accuracy Testing', 'description': 'Comparison between GenePOC PCR and Reference Method', 'interventionNames': ['Device: Comparison between GenePOC PCR and Reference Method']}], 'interventions': [{'name': 'Comparison between GenePOC PCR and Reference Method', 'type': 'DEVICE', 'description': 'Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.', 'armGroupLabels': ['Accuracy Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Wishard Health Services', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Medical Center University Laboratories', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Tricore Laboratory University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Patrice Allibert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Meridian Bioscience, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meridian Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}