Status:
RECRUITING
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis
Lead Sponsor:
Daniel Merenstein
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Medstar Health Research Institute
Conditions:
Sinus Infection
Acute Sinusitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Sinus infections are sometimes treated with oral antibiotics or nasal steroid sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter reme...
Detailed Description
One in seven adults are diagnosed with acute sinus infections (also known as rhinosinusitis or ARS) every year in the United States, for an annual total of 30 million office visits. Most acute sinus i...
Eligibility Criteria
Inclusion
- 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'').
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
3720 Patients enrolled
Trial Details
Trial ID
NCT06076304
Start Date
November 21 2023
End Date
December 1 2028
Last Update
July 14 2025
Active Locations (7)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
3
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
4
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033