Overview
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2024-05-01
2024-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Daniel MerensteinCollaborators:
Medstar Health Research Institute
Patient-Centered Outcomes Research Institute
Penn State College of Medicine
University of California, Los Angeles
University of Washington
University of Wisconsin, Madison
Virginia Commonwealth UniversityTreatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Budesonide
Clavulanic Acid
Clavulanic Acids
Criteria
Inclusion Criteria:○ 18-65 years old; AND experiencing ongoing symptoms or signs that suggest an acute sinus
infection lasting for 1-21 days, without any signs clinical improvement
Exclusion Criteria:
- allergy or intolerance to penicillin
- received systemic antibiotic therapy in the past 4 weeks
- prior sinus surgery
- 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
- unable to read, speak or understand English or Spanish
- hospitalization in past 5 days
- unable or unwilling to provide informed consent or comply with study protocol
requirements
- fever >39°C or 102°F; OR
- taking intranasal corticosteroids (INCS) regularly in the past two weeks