Comparing nasal steroid spray, saline rinses, and antibiotics for adults with acute sinus infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a large, pragmatic, randomized controlled trial enrolling adults 18–75 who present to primary or urgent care with symptoms of acute rhinosinusitis. Participants will be randomized to receive oral amoxicillin/clavulanate versus placebo and to receive budesonide nasal spray versus not, with supportive measures such as saline irrigation also used per protocol. The study includes a pre-randomization waiting period (9+ days) for some participants and uses subgroup analyses (for example, elevated CRP, double-sickening, or purulence on exam) to identify who benefits most from antibiotics. Sites are spread across multiple geographic regions and include academic and health system partners.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18-75 years old; AND are experiencing either:
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'').

Exclusion Criteria:

* 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's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Georgetown University Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Penn State College of Medicine
  Hershey, Pennsylvania, United States Recruiting
• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting
• University of Wisconsin-Madison
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Dan Merenstein, MD — Georgetown University
• Study coordinator: Lead Project Coordinator
• Email: researchfammed@georgetown.edu
• Phone: 202-687-6454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.