Recruiting

Observational Study

Sponsor:

Daniel Merenstein

Code:

NCT06076304

Conditions

Sinus Infection

Acute Sinusitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

amoxicillin/clavulanate potassium

Placebo

Budesonide nasal spray

Study Details

Brief summary:

Sinus infections (also called acute rhinosinusitis or ARS) affect about 15% of adults each year, and are one of the top reasons people receive antibiotics in outpatient settings. Since most sinus infections are caused by viruses, many patients who take antibiotics for this condition do not actually benefit. Even though this has decreased over recent years, 70% of people are still prescribed them after a visit for ARS. Our goal is to better understand which patients truly benefit from antibiotics and which other treatment options can help people with sinus infections.

Conditions

Sinus Infection

Acute Sinusitis

Study ID

NCT06076304

Start date

Nov 21, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3720 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: antibiotic

amoxicillin/clavulanate

placebo comparator: placebo antibiotic

placebo antibiotic (for amoxicillin/clavulanate)

active comparator: antibiotic plus intranasal corticosteroid

amoxicillin/clavulanate plus budesonide

other: placebo antibiotic plus intranasal corticosteroid

placebo antibiotic plus budesonide

Interventions

amoxicillin/clavulanate potassium

Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days

Placebo

Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days

Budesonide nasal spray

Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day

Primary outcome measure

  • Symptom Improvement [ Time Frame: Change from Day 1 to Day 3 in Phase 2; differences in longitudinal trends across groups during Phase 2 ]

Central Contacts and Locations

Central contacts

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Derjung Mimi Tarn, MD, PhD

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Principal Investigator:

Daniel Merenstein, MD

Penn State College of Medicine

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

David Rabago, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

Principal Investigator:

Alexander Krist, MD, MPH

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Sebastian Tong, MD, MPH

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Bruce Barrett, MD, PhD

More Information

Sponsor

Daniel Merenstein

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • sinusitis
  • antibiotics
  • intranasal corticosteroids
  • saline nasal irrigation
  • comparative effectiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Daniel Merenstein on 2026-03-03.