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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Daniel Merenstein
Study ID
NCT06076304
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Sinusitis
  • Sinus Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • amoxicillin/clavulanate potassium — DRUG
    Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days
  • Placebo — DRUG
    Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days
  • Budesonide nasal spray — DRUG
    Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day

Study Details

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.

Key Dates

Start date
Nov 21, 2023
Status verified
Feb 2026
Primary completion
Oct 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
3,720 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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

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

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Derjung Mimi Tarn, MD, PhD (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Daniel Merenstein, MD (PRINCIPAL_INVESTIGATOR)
MedStar Health Research InstituteHyattsvilleMaryland20782
Nawar Shara, PhD (PRINCIPAL_INVESTIGATOR)
Penn State College of MedicineHersheyPennsylvania17033
David Rabago, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23219
Alexander Krist, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Sebastian Tong, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Wisconsin-MadisonMadisonWisconsin53705
Bruce Barrett, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles· Los Angeles, CAGeorgetown University Medical Center· Washington D.C., DCMedStar Health Research Institute· Hyattsville, MDPenn State College of Medicine· Hershey, PAVirginia Commonwealth University· Richmond, VAUniversity of Washington· Seattle, WA