Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-05 @ 5:37 PM
Study NCT ID:
NCT06424704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Suppurative Otitis Media Microbiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D002781', 'term': 'Cholesteatoma'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Culture samples taken from the ears of patients with chronic suppurative otitis media with cholesteatoma and chronic suppurative otitis media without cholesteatom.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiology of chronic suppurative otitis media', 'timeFrame': '2024-2026 (24 months)', 'description': 'Microbiology in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma'}], 'secondaryOutcomes': [{'measure': 'Antibiotic susceptibility in chronic suppurative otitis media', 'timeFrame': '2024-2026 (24 months)', 'description': 'Investigation of antibiotic susceptibility and resistance in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic suppurative otitis media', 'Cholesteatoma', 'Ear discharge'], 'conditions': ['Otitis Media, Suppurative Chronic', 'Cholesteatoma', 'Microbial Colonization']}, 'referencesModule': {'references': [{'pmid': '37727177', 'type': 'BACKGROUND', 'citation': 'Khairkar M, Deshmukh P, Maity H, Deotale V. Chronic Suppurative Otitis Media: A Comprehensive Review of Epidemiology, Pathogenesis, Microbiology, and Complications. Cureus. 2023 Aug 18;15(8):e43729. doi: 10.7759/cureus.43729. eCollection 2023 Aug.'}, {'pmid': '16198004', 'type': 'BACKGROUND', 'citation': 'Verhoeff M, van der Veen EL, Rovers MM, Sanders EA, Schilder AG. Chronic suppurative otitis media: a review. Int J Pediatr Otorhinolaryngol. 2006 Jan;70(1):1-12. doi: 10.1016/j.ijporl.2005.08.021. Epub 2005 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'This study is planned to reveal the microbiological agents and drug sensitivities to these agents in patients diagnosed with chronic suppurative otitis media who complain of ear discharge.', 'detailedDescription': "Patients with complaints of ear discharge and who were diagnosed with chronic suppurative otitis media will be included in the study. Patients will be divided into two groups: CSOM with cholesteatoma and CSOM without cholesteatoma. One hundred ten patients from each group will be included in the study. After a comprehensive medical history is taken for each patient, the patient's external auditory canal will be cleaned with sterile aspirators. A sterile culture will be taken from the discharge of the ear and sent to microbiology. With the data obtained from microbiological examination, pathogens will be classified as gram-positive, gram-negative, anaerobic, and fungal and examined according to monomicrobial and polymicrobial growth. Antibiotic susceptibility tests will be conducted to determine the effectiveness of antibiotics against the bacteria causing the infection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases \\& Head and Neck Surgery, with complaints of ear discharge and were diagnosed with chronic suppurative otitis media.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with chronic suppurative otitis media\n2. Patients over 18 years of age\n\nExclusion Criteria:\n\n1. Chronic nonsuppurative otitis media patients\n2. Patients diagnosed with external ear canal/middle ear malignancy\n3. Patients who take immunosuppressive drugs\n4. Immunosuppressive patients\n5. Patients who used antibiotics (topical-systemic) in the last week'}, 'identificationModule': {'nctId': 'NCT06424704', 'briefTitle': 'Chronic Suppurative Otitis Media Microbiology', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Microbiology of Chronic Suppurative Otitis Media: Prospective Study', 'orgStudyIdInfo': {'id': '2024/145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic suppurative otitis media with cholesteatoma (Chole)', 'description': 'Patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases \\& Head and Neck Surgery with complaints of ear discharge and were diagnosed with chronic suppurative otitis media with cholesteatoma were included in the study.', 'interventionNames': ['Diagnostic Test: Microbiological culture']}, {'label': 'Chronic suppurative otitis media without cholesteatoma (CSOM)', 'description': 'The study included patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases \\& Head and Neck Surgery, with complaints of ear discharge and were diagnosed with chronic suppurative otitis media without cholesteatoma.', 'interventionNames': ['Diagnostic Test: Microbiological culture']}], 'interventions': [{'name': 'Microbiological culture', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Antibiotic susceptibility tests will be performed with the Kirby Bauer disc diffusion test and VITEK2 automated system (bioMerieux, France).'], 'description': 'Samples taken from chronic suppurative otitis media patients in the Medical Microbiology Laboratory of Selçuk University Faculty of Medicine will be planted in 5% sheep blood Columbia agar, eosin methylene blue agar and saboraud dextrose agar, and the media will be incubated at 37oC for 24-48 hours. Growing bacteria and fungi were examined using traditional methods \\[Gram staining, catalase test, coagulase test, bacitracin disk, PYR test (L-pyrrolidonyl-β-naphthylamide), oxidase test, IMViC test, lactophenol cotton blue, etc.\\] and VITEK 2 (bioMerieux, France).', 'armGroupLabels': ['Chronic suppurative otitis media with cholesteatoma (Chole)', 'Chronic suppurative otitis media without cholesteatoma (CSOM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Konya', 'state': 'Selcuklu', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Bulent ulusoy', 'role': 'CONTACT'}], 'facility': 'Bulent ULUSOY', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'zip': '42100', 'city': 'Konya', 'state': 'Selcuklu', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'centralContacts': [{'name': 'Burcu Tuğba Aldora', 'role': 'CONTACT', 'email': 'etikselcuk@gmail.com', 'phone': '+905437608870'}], 'overallOfficials': [{'name': 'Bulent Ulusoy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Selcuk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Selcuk University Faculty of Medicine', 'investigatorFullName': 'Bulent Ulusoy', 'investigatorAffiliation': 'Selcuk University'}}}}