Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT05305534
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'positive blood culture clinical samples and pure colony samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2142}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPA', 'timeFrame': '6 moths', 'description': 'positive percentage agreement'}, {'measure': 'NPA', 'timeFrame': '6 moths', 'description': 'negative percentage agreement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Disease']}, 'descriptionModule': {'briefSummary': 'Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods', 'detailedDescription': 'This multicenter study aims to evaluate the performance of QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel with another validated comparator method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suspected of bloodstream infection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU.\n* Residual and de-identified specimens.\n* Specimen from subject who has not previously been enrolled.\n* Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity.\n* Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity.\n* Minimum 1.5 mL volume available\n* In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales.\n\nExclusion Criteria:\n\n* Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids)\n* Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected).\n* Frozen specimens which are unable to be cultured after thawing.\n* Specimen from subject previously enrolled"}, 'identificationModule': {'nctId': 'NCT05305534', 'briefTitle': 'QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'QIAGEN Gaithersburg, Inc'}, 'officialTitle': 'Clinical Performance Evaluation Study of the QIAstat-Dx® BCID GN and GPF Plus AMR Panels on Positive Blood Culture and Pure Colony Isolates From Subjects With Signs and Symptoms of Bloodstream Infection', 'orgStudyIdInfo': {'id': 'SMF-18-0136-1-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'QIAstat-Dx® BCID GN and GPF Plus AMR Panels', 'type': 'DEVICE', 'description': 'The performance of QIAstat-Dx® BCID GN and GPF Plus AMR Panels will be evaluated in comparison with another validated comparator method, using residual specimens of positive blood culture. Pure colonies derived from the residual positive blood culture specimens will also be tested'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'QIAGEN', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sarah Johnson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QIAGEN Gaithersburg, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'all samples are residual and anonymized'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QIAGEN Gaithersburg, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}