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RecruitingNCT06023550ENT_infectUpdated Apr 29, 2026

Complicated Infections in Otorhinolaryngology

An observational study in Sinusitis, Otitis and Laryngitis, sponsored by University Medical Centre Ljubljana. Recruiting at 1 site in Slovenia. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University Medical Centre Ljubljana · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,550
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sinusitis
  • Otitis
  • Laryngitis
  • Lymphadenitis
  • Quinsy
  • Peritonsillar Abscess
  • Parapharyngeal Abscess
  • Preseptal Cellulitis
  • Subperiosteal Abscess
  • Orbital Abscess
  • Epiglottitis
03

In context

Sinusitis

256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.

This study's planned enrollment of 2,550 is above the median of 125 across 44 observational studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • disagreement of the patient and/or parents (or legal guardians) with inclusion in the research,
  • failure to meet the inclusion criteria.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,550 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherTreatment with surgery and/or conservative measures

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

06

What researchers measure

Primary outcomes

  1. Disease free survival

    Number of living patients without a disease

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06023550
Responsible party
Domen Vozel, MD, PhD (Domen Vozel, MD, PhD, ENT specialist, University Medical Centre Ljubljana) — Principal investigator
First posted
Sep 5, 2023
Start date
Sep 1, 2024
Primary completion
Sep 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Apr 29, 2026

Study contacts

Domen Vozel, MD, PhD
Contact
domen.vozel@kclj.si
+38615223280
Domen Vozel, MD, PhD
principal investigator · Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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