Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT05681156
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2022-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2022-12-27', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays', 'timeFrame': '7 months', 'description': 'Curian S. pneumo/Legionella Assay will be compared to the comparator assays (both FDA cleared)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Streptococcus Pneumoniae Infection', 'Legionella Pneumophila Serogroup 1 Infection']}, 'referencesModule': {'references': [{'pmid': '35953247', 'type': 'BACKGROUND', 'citation': 'Yasuo S, Murata M, Nakagawa N, Kawasaki T, Yoshida T, Ando K, Okamori S, Okada Y; Japanese ARDS clinical practice guideline systematic review task force. Diagnostic accuracy of urinary antigen tests for pneumococcal pneumonia among patients with acute respiratory failure suspected pneumonia: a systematic review and meta-analysis. BMJ Open. 2022 Aug 11;12(8):e057216. doi: 10.1136/bmjopen-2021-057216.'}, {'pmid': '31587039', 'type': 'BACKGROUND', 'citation': 'Schimmel JJ, Haessler S, Imrey P, Lindenauer PK, Richter SS, Yu PC, Rothberg MB. Pneumococcal Urinary Antigen Testing in United States Hospitals: A Missed Opportunity for Antimicrobial Stewardship. Clin Infect Dis. 2020 Sep 12;71(6):1427-1434. doi: 10.1093/cid/ciz983.'}]}, 'descriptionModule': {'briefSummary': 'Beta trial to evaluate the preliminary clinical performance of the Curian S. pneumo/Legionella assay for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.', 'detailedDescription': 'This study will evaluate the preliminary clinical performance of the RUO Curian S. pneumo/Legionella assay against two FDA cleared comparators for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients arriving at hospital with suspected pneumonia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males and females, with symptom of pneumonia and for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has been ordered by a practicing physician.\n* At least 2mL of urine from fresh de-identified clinical specimen from standard of care lab testing\n* Only one (1) specimen per patient will be included in the study\n* Materials used within their expiration date\n* Storage time and conditions within requested indications listed on RUO Package Insert\n\nExclusion Criteria:\n\n* Specimens from patients for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has not been ordered\n* Storage times and conditions that exceed these study protocol requirements listed on RUO Package Insert\n* Urine samples provided in unsatisfactory conditions'}, 'identificationModule': {'nctId': 'NCT05681156', 'briefTitle': 'Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meridian Bioscience, Inc.'}, 'officialTitle': 'Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol', 'orgStudyIdInfo': {'id': 'CLIN0015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspected pneumonia', 'description': 'Leftover de-identified samples from standard of care will be taken from patients suspected of having pneumonia due to Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 infection.', 'interventionNames': ['Other: N/A- There is no intervention.']}], 'interventions': [{'name': 'N/A- There is no intervention.', 'type': 'OTHER', 'description': 'There is no intervention.', 'armGroupLabels': ['Patients with suspected pneumonia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'No plan yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meridian Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}