Status:
UNKNOWN
Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care
Lead Sponsor:
Dominik Glinz
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Acute Bacterial Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot study to assess the first time use of the JGG endoscope® in humans and in primary care. The JGG endoscope® is attached to a Heine® otoscope and allows to inspect and to collect samples...
Detailed Description
Acute rhinosinusitis is one of the most common reasons for consultations and antibiotic prescriptions in primary care although the condition is primarily of viral origin. The main reason for antibioti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03766568
Start Date
December 17 2018
End Date
September 30 2020
Last Update
January 14 2020
Active Locations (6)
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1
Praxis Vogt
Liestal, Basel-Landschaft, Switzerland, 4410
2
Hausarztpraxis Muttenz AG
Muttenz, Basel-Landschaft, Switzerland, 4132
3
mediX toujours Pratteln
Pratteln, Basel-Landschaft, Switzerland, 4133
4
HNO Klinik, University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031