Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Daniel Merenstein
3,720 participants
Nov 21, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- years old; AND are experiencing either:
- "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
- 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 Criteria12
- 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
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Interventions
Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days
Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days
Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06076304