Complicated Infections in Otorhinolaryngology (ENT_infect)

May 6, 2024 updated by: Domen Vozel, MD, PhD, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

2550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complicated sinonasal infection
Group of patients with a complicated sinonasal infection, including local or systemic complications.
Other: Treatment with surgery and/or conservative measures
Patients will be treated according to established clinical practice 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
Patients will be treated according to established clinical practice 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
Patients will be treated according to established clinical practice 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
Patients will be treated according to established clinical practice with surgery and/or conservative measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 12 months
Number of living patients without a disease
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Domen Vozel, MD, PhD, Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENT infections

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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