SinusitisENT_infectNCT06023550
Complicated Infections in Otorhinolaryngology
An observational study of Sinusitis and Otitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sinusitis, Otitis, Laryngitis
- What is being tested?
- Treatment with surgery and/or conservative measures
- How many people
- 2,550 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2024to Sep 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with complicated infections treated by otorhinolaryngologists in the tertiary otorhinolaryngology referral centre.
Who may be able to join
- 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.
Who cannot join
- disagreement of the patient and/or parents (or legal guardians) with inclusion in the research,
- failure to meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, Ljubljana, 1000
Domen Vozel, MD, PhD, domen.vozel@kclj.si
About this study
Official title: 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.
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.
- Conditions
- Sinusitis, Otitis, Laryngitis, Lymphadenitis, Quinsy, Peritonsillar Abscess
- Being tested
- Treatment with surgery and/or conservative measures
- Medical subject headings
- Sinusitis, Otitis, Laryngitis, Lymphadenitis, Peritonsillar Abscess, Orbital Cellulitis, Epiglottitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with surgery and/or conservative measuresOther
Patients will be treated according to established clinical practice with surgery and/or conservative measures.
| Study group | Role | What they receive |
|---|---|---|
| Complicated sinonasal infection | Group of patients with a complicated sinonasal infection, including local or systemic complications. Receives: 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. Receives: 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. Receives: Other: Treatment with surgery and/or conservative measures | |
| Complicated laryngeal infection | Group of patients with a complicated laryngeal infection, including local or systemic complications. Receives: Other: Treatment with surgery and/or conservative measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Number of living patients without a disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,550 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domen Vozel, MD, PhD, University Medical Centre Ljubljana
- Investigators
- Domen Vozel, MD, PhD, Principal investigator, Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023550
- Sponsor's protocol ID
- ENT infections
- Acronym
- ENT_infect
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Complicated Infections in Pediatric and Adult Populations Treated by Otorhinolaryngologist
- ClinicalTrials.gov ID
- NCT06023550
- Acronym / sponsor ID
- ENT_infect / ENT infections
- Conditions
- Sinusitis, Otitis, Laryngitis, Lymphadenitis, Quinsy, Peritonsillar Abscess
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,550 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Complicated sinonasal infection | – | Other: Treatment with surgery and/or conservative measuresGroup of patients with a complicated sinonasal infection, including local or systemic complications. |
| Complicated ear or temporal bone infection | – | Other: Treatment with surgery and/or conservative measuresGroup of patients with a complicated ear or temporal bone infection, including local or systemic complications. |
| Complicated neck soft tissue infection | – | Other: Treatment with surgery and/or conservative measuresGroup of patients with a complicated neck soft tissue infection, including local or systemic complications. |
| Complicated laryngeal infection | – | Other: Treatment with surgery and/or conservative measuresGroup of patients with a complicated laryngeal infection, including local or systemic complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with complicated infections treated by otorhinolaryngologists in the tertiary otorhinolaryngology referral centre.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- disagreement of the patient and/or parents (or legal guardians) with inclusion in the research,
- failure to meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with surgery and/or conservative measuresPatients will be treated according to established clinical practice with surgery and/or conservative measures. | Other | Complicated ear or temporal bone infection, Complicated laryngeal infection, Complicated neck soft tissue infection, Complicated sinonasal infection |
Primary outcome
Disease free survival
Time frame: 12 months
Number of living patients without a disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Domen Vozel, MD, PhD principal investigator
Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis and Otitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domen Vozel, MD, PhD (+38615223280, domen.vozel@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.