Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Details

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 infections seen in outpatient setting are caused by viral infection, but antibiotics are prescribed in over 70% of these visits. The overarching goal is to improve outcomes for patients with ARS by understanding which subgroups are most likely to benefit from antibiotics, supportive care, watchful waiting, intranasal corticosteroids (INCS), or a combination of treatments. To assess the comparative effectiveness of the treatments, a large, pragmatic, randomized controlled trial, will be conducted in practice-based research networks within six geographical areas. Enrolled adults ages 18-75 years presenting to a clinician with symptoms consistent with ARS for less than 10 days will begin with a pre-randomization period with options for supportive care. Patients who reached more than 9 days of symptoms at the time of enrollment or during the waiting period will be randomly assigned to one of the four treatment arms.

Keywords

Sinus Infection, Acute Sinusitis, sinusitis, antibiotics, intranasal corticosteroids, saline nasal irrigation, comparative effectiveness, Anti-Bacterial Agents, Amoxicillin, Clavulanic Acid, Clavulanic Acids, Amoxicillin-Potassium Clavulanate Combination, Budesonide, Amoxicillin/clavulanate, Budesonide nasal spray, C-reactive protein, Mid-turbinate swab (optional), antibiotic, antibiotic plus intranasal corticosteroid

Eligibility

You can join if…

Open to people ages 18-75

  1. 18-75 years old; AND are experiencing:
  2. "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
  3. 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 CAN'T join if...

  • 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

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • University of Washington
    Seattle Washington 98195 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daniel Merenstein
ID
NCT06076304
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 3720 study participants
Last Updated