Complicated Infections in Otorhinolaryngology

NCT06023550 | Recruiting

• 1 other identifier: ENT infections
• Study Type: observational
• Target: 2,550
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngitis; Quinsy; Preseptal Cellulitis; Orbital Abscess; Epiglottitis; Sinusitis; Otitis; Lymphadenitis; Peritonsillar Abscess; Parapharyngeal Abscess; Subperiosteal Abscess

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Number of living patients without a disease

  12 months

Study Arms (4)

Complicated sinonasal infection

Group of patients with a complicated sinonasal infection, including local or systemic complications.

Other: Treatment with surgery and/or conservative measures

Complicated ear or temporal bone infection

Group of patients with a complicated ear or temporal bone infection, including local or systemic complications.

Other: Treatment with surgery and/or conservative measures

Complicated neck soft tissue infection

Group of patients with a complicated neck soft tissue infection, including local or systemic complications.

Other: Treatment with surgery and/or conservative measures

Complicated laryngeal infection

Group of patients with a complicated laryngeal infection, including local or systemic complications.

Other: Treatment with surgery and/or conservative measures

Interventions

Treatment with surgery and/or conservative measures OTHER

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

Complicated ear or temporal bone infection; Complicated laryngeal infection; Complicated neck soft tissue infection; Complicated sinonasal infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with complicated infections treated by otorhinolaryngologists in the tertiary otorhinolaryngology referral centre.

You may qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Sinusitis; Otitis; Laryngitis; Lymphadenitis; Peritonsillar Abscess; Orbital Cellulitis; Epiglottitis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Laryngeal Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Tonsillitis; Pharyngitis; Abscess; Suppuration; Pharyngeal Diseases; Stomatognathic Diseases; Orbital Diseases; Eye Diseases; Cellulitis; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Supraglottitis

Study Officials

• Domen Vozel, MD, PhD

  Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domen Vozel, MD, PhD

CONTACT

+38615223280; domen.vozel@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Domen Vozel, MD, PhD, ENT specialist

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 5, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)