Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT05183906
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2021-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing for Microbiological Assessment in Infectious Keratitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007634', 'term': 'Keratitis'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of clinically relevant microorganisms identified using culture or next generation sequencing', 'timeFrame': '1 year'}, {'measure': 'Comparison of clinically relevant identified microorganisms on a genus level', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratitis']}, 'descriptionModule': {'briefSummary': 'Infectious keratitis is a potential sight threatening condition. In conventional clinical practice culturing is performed in order to identify the causative microbial organism; however in recent years Next Generation Sequencing for the presence of ribosomal DNA from bacteria, fungi, or amoeba has become available. The present study aims to compare conventional culturing with Next Generation Sequencing for identifying microorganism causing keratitis.', 'detailedDescription': "Patients admitted with microbial keratitis to the department of ophthalmology at Aarhus University Hospital is evaluated with both conventional culturing at agar plates, broth culture, and Next Generation Sequencing for ribosomal DNA.\n\nOnly patients with a corneal infiltrate of a minimum of 2 mm or of 1 mm within the central 6 mm of the cornea will be included in the study.\n\nSampling includes two samples from the contralateral healthy eye to control for the patient's normal microbiome, evaluated with culturing in broth and with NGS.\n\nFrom the infiltrate, samples include culturing on Sabouraud agar, chocolate agar, and blood agar, culturing in broth medium, and samples for NGS.\n\nA total of 100 patients will be included."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with keratitis admitted to tertiary ophthalmological unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with a corneal infiltrate of minimum 2 mm in diameter or of 1 mm diameter within the central 6 mm of the cornea\n\nExclusion Criteria:\n\n\\- Patients below 18 years of age'}, 'identificationModule': {'nctId': 'NCT05183906', 'briefTitle': 'Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing for Microbiological Assessment in Infectious Keratitis', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing in Infectious Keratitis', 'orgStudyIdInfo': {'id': 'KeratitisMicrobiome'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Next generation sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of microbiological culturing versus next generation sequencing for ribosomal DNA'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8000', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anders Ivarsen, MD, PhD', 'role': 'CONTACT', 'email': 'ai@dadlnet.dk', 'phone': '+4575483247'}, {'name': 'Anders Ivarsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Ophthalmology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Associate Professor', 'investigatorFullName': 'Anders Ivarsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}