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NCT06023550 Clinical Trial

Complicated Infections in Otorhinolaryngology

Sinusitis Clinical Trial

— ENT_infect  

Official title:
Analysis of Complicated Infections in Pediatric and Adult Populations Treated by Otorhinolaryngologist

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06023550
Other study ID # ENT infections
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2024
Est. completion date September 2028

Study information
Verified date May 2024
Source University Medical Centre Ljubljana
Contact Domen Vozel, MD, PhD
Phone +38615223280
Email domen.vozel@kclj.si
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are: - What is the management of complicated sinonasal infections in Ljubljana, Slovenia, - What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia, - What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia, - What is the management of complicated laryngeal infections in Ljubljana, Slovenia Participants will receive standard treatment according to the established evidence-based clinical practice.

Description:

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. The 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. The main questions to answer are: - What is the management of complicated sinonasal infections in Ljubljana, Slovenia, - What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia, - What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia, - What is the management of complicated laryngeal infections in Ljubljana, Slovenia Participants will receive standard treatment according to the established evidence-based clinical practice.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2550
Est. completion date September 2028
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 - complication of inflammation of the nose and paranasal cavities AND/OR ear AND/OR temporal bone AND/OR: - treated at the Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Center Ljubljana. Exclusion Criteria: - disagreement of the patient and/or parents (or legal guardians) with inclusion in the research, - failure to meet the inclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Treatment with surgery and/or conservative measures
Patients will be treated according to established clinical practice with surgery and/or conservative measures.

Locations
Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease free survival Number of living patients without a disease 12 months
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