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

PLACER-2021C3-24476

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.

2023-11-21

2024-05-01

2024-05-01

Active (not recruiting)

Early phase I

144

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}

2024-05-23