Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-04 @ 4:19 PM
Study NCT ID:
NCT06023550
Status:
RECRUITING
Last Update Posted:
2024-09-26
First Post:
2023-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complicated Infections in Otorhinolaryngology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D007827', 'term': 'Laryngitis'}, {'id': 'D008199', 'term': 'Lymphadenitis'}, {'id': 'D000039', 'term': 'Peritonsillar Abscess'}, {'id': 'D054517', 'term': 'Orbital Cellulitis'}, {'id': 'D004826', 'term': 'Epiglottitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014069', 'term': 'Tonsillitis'}, {'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D059525', 'term': 'Supraglottitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2550}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2023-08-27', 'studyFirstSubmitQcDate': '2023-08-27', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '12 months', 'description': 'Number of living patients without a disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sinusitis', 'Otitis', 'Laryngitis', 'Lymphadenitis', 'Quinsy', 'Peritonsillar Abscess', 'Parapharyngeal Abscess', 'Preseptal Cellulitis', 'Subperiosteal Abscess', 'Orbital Abscess', 'Epiglottitis']}, 'descriptionModule': {'briefSummary': 'This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are:\n\n* What is the management of complicated sinonasal infections in Ljubljana, Slovenia,\n* What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,\n* What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia,\n* What is the management of complicated laryngeal infections in Ljubljana, Slovenia\n\nParticipants will receive standard treatment according to the established evidence-based clinical practice.', 'detailedDescription': 'The main purpose of the research is to obtain own data on the treatment of patients with infections in ENT areas that require targeted treatment by an otolaryngologist at the hospital level. Based on these results, treatment outcome would be improved and hospitalization time would be shortened. We would establish clinical pathways for the treatment of these diseases in Slovenia. There is still no data on the treatment of these diseases in ENT departments in Slovenia, so one of the main purposes of the research is to obtain objective indicators of the success of treatment in comparison with other countries and a rough epidemiological assessment of the disease in Slovenia.\n\nThe research would establish a database of patients with complicated infections in ENT areas at the University Clinical Center Ljubljana, which would be used for prospective analysis even after the research was completed. The register would also enable transparency in the treatment of these patients in the future.\n\nThe main questions to answer are:\n\n* What is the management of complicated sinonasal infections in Ljubljana, Slovenia,\n* What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,\n* What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia,\n* What is the management of complicated laryngeal infections in Ljubljana, Slovenia\n\nParticipants will receive standard treatment according to the established evidence-based clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with complicated infections treated by otorhinolaryngologists in the tertiary otorhinolaryngology referral centre.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnoses: rhinitis AND/OR sinusitis AND/OR facial cellulitis AND/OR facial abscess AND/OR nasal furuncle AND/OR infection of the outer AND/OR middle AND/OR inner ear AND/OR temporal bone AND/OR infection of the soft tissues of the neck with/without bone and cartilage involvement AND/OR laryngitis AND/OR epiglottitis (or supraglottitis) AND/OR\n* complication of inflammation of the nose and paranasal cavities AND/OR ear AND/OR temporal bone AND/OR:\n* treated at the Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Center Ljubljana.\n\nExclusion Criteria:\n\n* disagreement of the patient and/or parents (or legal guardians) with inclusion in the research,\n* failure to meet the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06023550', 'acronym': 'ENT_infect', 'briefTitle': 'Complicated Infections in Otorhinolaryngology', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Analysis of Complicated Infections in Pediatric and Adult Populations Treated by Otorhinolaryngologist', 'orgStudyIdInfo': {'id': 'ENT infections'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Complicated sinonasal infection', 'description': 'Group of patients with a complicated sinonasal infection, including local or systemic complications.', 'interventionNames': ['Other: Treatment with surgery and/or conservative measures']}, {'label': 'Complicated ear or temporal bone infection', 'description': 'Group of patients with a complicated ear or temporal bone infection, including local or systemic complications.', 'interventionNames': ['Other: Treatment with surgery and/or conservative measures']}, {'label': 'Complicated neck soft tissue infection', 'description': 'Group of patients with a complicated neck soft tissue infection, including local or systemic complications.', 'interventionNames': ['Other: Treatment with surgery and/or conservative measures']}, {'label': 'Complicated laryngeal infection', 'description': 'Group of patients with a complicated laryngeal infection, including local or systemic complications.', 'interventionNames': ['Other: Treatment with surgery and/or conservative measures']}], 'interventions': [{'name': 'Treatment with surgery and/or conservative measures', 'type': 'OTHER', 'description': 'Patients will be treated according to established clinical practice with surgery and/or conservative measures.', 'armGroupLabels': ['Complicated ear or temporal bone infection', 'Complicated laryngeal infection', 'Complicated neck soft tissue infection', 'Complicated sinonasal infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Domen Vozel, MD, PhD', 'role': 'CONTACT', 'email': 'domen.vozel@kclj.si'}], 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Domen Vozel, MD, PhD', 'role': 'CONTACT', 'email': 'domen.vozel@kclj.si', 'phone': '+38615223280'}], 'overallOfficials': [{'name': 'Domen Vozel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Domen Vozel, MD, PhD, ENT specialist', 'investigatorFullName': 'Domen Vozel, MD, PhD', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}