Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03766568
Eligibility Criteria:
Inclusion Criteria:
* Adults patients aged ≥18 years, with acute rhinosinusitis
* Duration: worsening of symptoms after 5 days after onset of symptoms or if symptoms persist for more than 10 days, but no longer than 28 days. In addition, Criteria 1 and 2 must be fulfilled.
Criteria 1 for acute rhinosinusitis:
\[Nasal blockage/obstruction/congestion OR Nasal Discharge (anterior/ posterior nasal drip)\] AND \[Facial pain/ pressure OR Reduction or loss of smell\]
Criteria 2 for acute bacterial rhinosinusitis
Indicated by the presence of at least one of the following symptoms:
* discoloured discharge (unilateral predominance)
* severe local pain (unilateral predominance)
* fever, that is \>38°C
* elevated inflammatory markers (CRP)
* 'double sickening' whereby the patient's condition deteriorates.
Exclusion Criteria:
* Not being able to provide written informed consent in German (due to any mental or intellectual problem or other reasons)
* Not being available for follow-up
* Previous participation in Sinus-Endo study
* Use of antibiotic the last 4 weeks
* Known pathology or malformation of the sinuses or nasal cavity (like polyposis)
* Known pregnancy
* Allergic reactions to local anaesthetics
* Anticoagulation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03766568
Study Brief:
Protocol Section:
NCT03766568