← Back to Clinical Trials
Recruiting Phase 4 NCT06076304

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

Trial Parameters

Condition Sinus Infection
Sponsor Daniel Merenstein
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 3,720
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-11-21
Completion 2028-10
Interventions
amoxicillin/clavulanate potassiumPlaceboBudesonide nasal spray

Brief Summary

Sinus infections (also called acute rhinosinusitis or ARS) affect about 15% of adults each year, and are one of the top reasons people receive antibiotics in outpatient settings. Since most sinus infections are caused by viruses, many patients who take antibiotics for this condition do not actually benefit. Even though this has decreased over recent years, 70% of people are still prescribed them after a visit for ARS. Our goal is to better understand which patients truly benefit from antibiotics and which other treatment options can help people with sinus infections.

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), cellulit

Related Trials