Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06023550

Complicated Infections in Otorhinolaryngology

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment with surgery and/or conservative measures

Other

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

Primary outcomes

  1. Disease free survival

    Time frame: 12 months

    Number of living patients without a disease

Study contacts

Contact information is provided by the study sponsor or research team.

Domen Vozel, MD, PhD

CONTACT

[email protected]

+38615223280

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Acronym: ENT_infect

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 5, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.