Complicated Infections in Otorhinolaryngology | NCT06023550

Studies
Complicated Infections in Otorhinolaryngology

NCT06023550

Sponsor

University Medical Centre Ljubljana

Status

Recruiting

Last Update Posted

Apr 29, 2026Actual

Enrollment

2,550Estimated

Phase

Not provided

Conditions

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

Interventions

Treatment with surgery and/or conservative measures

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Sep 2028Estimated

First Submitted Date

Aug 27, 2023

First Submission Date that Met QC Criteria

Aug 27, 2023

First Posted Date

Sep 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

Apr 29, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Domen Vozel, MD, PhD, Domen Vozel, MD, PhD, ENT specialist, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,550Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Domen Vozel, MD, PhD	Contact	+38615223280		domen.vozel@kclj.si

Overall Officials

Name	Affiliation	Role
Domen Vozel, MD, PhD	Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana	Recruiting	Ljubljana	Ljubljana	1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012852	Sinusitis
D010031	Otitis
D007827	Laryngitis
D008199	Lymphadenitis
D000039	Peritonsillar Abscess
D054517	Orbital Cellulitis
D004826	Epiglottitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided