NCT05955859 Diagnostics of Mycotic Sinusitis in ENT Patients
| NCT ID | NCT05955859 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Ostrava |
| Condition | Fungal Sinusitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2023-05-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mycotic sinusitis is a rare inflammatory disease of the paranasal sinuses. In recent years, its occurrence is increasing. Due to this situation, mycotic sinusitis is gaining importance, even though most cases of mycotic sinusitis are limited on paranasal sinuses. Non-invasive forms of mycotic sinusitis are divided into mycetoma and allergic mycotic sinusitis. Mycetoma (fungus ball) usually affects only one paranasal sinus, most often maxillary sinus. The predisposing factors which participate on development of mycotic sinusitis are not exactly known. Some factors are considered as possible predisposing factors, for example deviation of nasal septum, dental treatment of upper jaw teeth or changes of nasal microbiome. The diagnosis of fungal sinusitis is problematic. With the increasing number of patients, it is essential to improve the diagnostic process. In present, suspicion of mycotic sinusitis is based on the patient's clinical symptoms and the endoscopic findings in the nasal cavity. Only in some cases nonspecific findings can be observed, such as smelly secretions from the nose, feeling of stuffy nose and pain over the affected sinus. Some patients may be completely asymptomatic, and only in some cases fungal masses can be observed in the nasal cavity. Computed tomography (CT) scans are gaining more and more importance. Typical sign of an affected sinus is obfuscation on CT scan but this sign is not specific for mycotic infection. Central hyperdense foci are also present in some patients, but they are also not specific and can imitate a foreign body. Identifying specific signs on CT scan could help with diagnosing mycotic sinusitis.
Eligibility Criteria
Inclusion Criteria: * age ≥ 18 years * patients with unilateral obfuscation of the paranasal sinus and patients with unilateral discharge from the nasal cavity Exclusion Criteria: * serious illness (decompensation phase) - cardiac, liver, kidney disease, can-cer * serious psychiatric illnesses * pregnancy * high operative risk according to The American Society of Anesthesiologists (ASA) ≥ IV * disagreement with participation in the study
Contact & Investigator
Simona Polášková, MD
PRINCIPAL INVESTIGATOR
University Hospital Ostrava
Frequently Asked Questions
Who can join the NCT05955859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fungal Sinusitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05955859 currently recruiting?
Yes, NCT05955859 is actively recruiting participants. Contact the research team at jiri.hyncica@fno.cz for enrollment information.
Where is the NCT05955859 trial being conducted?
This trial is being conducted at Ostrava, Czechia.
Who is sponsoring the NCT05955859 clinical trial?
NCT05955859 is sponsored by University Hospital Ostrava. The principal investigator is Simona Polášková, MD at University Hospital Ostrava. The trial plans to enroll 65 participants.