Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis

Launched by DANIEL MERENSTEIN · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the best ways to treat sinus infections, also known as acute sinusitis. Researchers are looking to see how different treatments, such as nasal steroid sprays, saline nasal irrigation (which is like rinsing the nose with salt water), and oral antibiotics, can help specific groups of patients. They want to find out who benefits most from these treatments and who might improve simply by using over-the-counter remedies or waiting a few days to see if their symptoms get better on their own.

To participate in this study, you need to be between 18 and 75 years old and have been experiencing symptoms of a sinus infection for 1 to 21 days without feeling better. Symptoms include things like facial pain, nasal congestion, and fever. However, some people may not qualify, such as those who have had certain recent medical treatments or conditions that could affect their immune system. If you join the trial, you will be monitored closely and receive care based on the study's findings, which could help improve treatment for sinus infections in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 18-75 years old; AND are experiencing either:
• • 2. "persistent" symptoms or signs compatible with ARS or sinus infection lasting for 1-21 days without any evidence of clinical improvement (Symptoms include facial pain or pressure, facial congestion or fullness, nasal obstruction, nasal discharge, no or reduced sense of smell, fever ≤39°C or 102°F, headache, bad smelling breath, fatigue, ear pain or pressure, and dental pain); OR
• • 3. onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge following a typical viral upper respiratory infection (URI) that lasted 5-6 days and were initially improving (''double-sickening'').
• Exclusion Criteria:
• • allergy or intolerance to penicillin
• • received systemic antibiotic therapy in the past 4 weeks
• • prior sinus surgery (cosmetic surgery, such as rhinoplasty, septal deviation, etc. are not exclusionary)
• • complications of sinusitis (facial edema (swelling), cellulitis), or orbital, meningeal or cerebral signs)
• • health care clinician determined IV (intravenous) antibiotics or hospital admission are required
• • pregnancy or breastfeeding
• • presence of a comorbidity or medication that may impair a patient's immune response as determined by a health care clinician
• • hospitalization in past 5 days
• • unable or unwilling to provide informed consent or comply with study protocol requirements
• • fever \>39°C or 102°F today
• • taking intranasal corticosteroids (INCS) regularly in the past two weeks and unwilling to stop its use while in the study; OR
• • previously enrolled or participated in the feasibility phase or this stage of study