Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Sinus Infection, Acute Sinusitis
In brief
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.
Key facts
- Study ID
- NCT06076304
- Run by
- Daniel Merenstein
- People needed
- 3720
- Starts
- 2023-11-21
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-75 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'').
You may not qualify if…
- 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
Where it is running
- Penn State College of Medicine — Hershey, Pennsylvania, United States (enrolling)
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (enrolling)
- University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
- University of Washington — Seattle, Washington, United States (enrolling)
- MedStar Health Research Institute — Hyattsville, Maryland, United States
Full record on ClinicalTrials.gov
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