Home › NCT06076304
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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 studyAbout the study
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.
What is being tested
- amoxicillin/clavulanate potassium (drug)
- Placebo (drug)
- Budesonide nasal spray (drug)
Sponsor: Daniel Merenstein · Participants: 3,720 · Started: Nov 21, 2023
Contact the study team
- Lead Project Coordinator · Phone: 202-687-6454
Official record on ClinicalTrials.gov — NCT06076304
Locations in the U.S.
| California | University of California, Los Angeles, Los Angeles |
| District of Columbia | Georgetown University Medical Center, Washington D.C. |
| Maryland | MedStar Health Research Institute, Hyattsville (Not yet recruiting) |
| Pennsylvania | Penn State College of Medicine, Hershey |
| Virginia | Virginia Commonwealth University, Richmond |
| Washington | University of Washington, Seattle |
| Wisconsin | University of Wisconsin-Madison, Madison |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.