Actively Recruiting
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Led by Daniel Merenstein · Updated on 2026-03-03
3720
Participants Needed
7
Research Sites
8 weeks
Total Duration
On this page
Sponsors
D
Daniel Merenstein
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute sinus infections, also called acute rhinosinusitis (ARS), affect about 15% of adults annually and are a common reason for antibiotic prescriptions despite most cases being caused by viruses. This research aims to understand which patients with ARS truly benefit from antibiotics and other treatments, improving care by identifying subgroups that respond best to specific therapies. The study is a large, pragmatic, randomized controlled trial enrolling adults aged 18 to 75 with symptoms consistent with ARS. Participants enter two phases: Phase 1 is a waiting period of up to 9 days with options for supportive care, during which symptom progress is monitored. Those who do not improve or who meet certain criteria move to Phase 2, where they are randomly assigned to one of four groups receiving either amoxicillin/clavulanate, placebo antibiotic, amoxicillin/clavulanate plus budesonide nasal spray, or placebo antibiotic plus budesonide. Treatments are given over 7 to 14 days, with dosing schedules including oral antibiotics twice daily and budesonide nasal spray once daily. Throughout both phases, participants complete daily diaries and periodic follow-ups to track symptom changes, supportive care use, and side effects. Researchers measure symptom improvement from day 1 to day 3 in Phase 2 as the primary outcome, along with additional assessments of quality of life, work productivity, adherence, and adverse events. The total study period includes up to 9 days of observation and 14 days of randomized treatment with ongoing monitoring to better target effective management for ARS.
CONDITIONS
Brief Title
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Symptoms compatible with acute rhinosinusitis lasting 1 to 21 days without improvement
- Or worsening symptoms (new fever, headache, or increased nasal discharge) after initial improvement from a viral upper respiratory infection
You will not qualify if you...
- Allergy or intolerance to penicillin
- Received systemic antibiotics in the past 4 weeks
- Prior sinus surgery (except cosmetic procedures)
- Sinusitis complications such as swelling, cellulitis, or signs affecting eyes or brain
- Need for intravenous antibiotics or hospital admission
- Pregnancy or breastfeeding
- Comorbidities or medications impairing immune response as determined by a clinician
- Hospitalization in the past 5 days
- Unable or unwilling to provide informed consent or comply with study requirements
- Fever over 39°C (102°F) at screening
- Regular use of intranasal corticosteroids in the past two weeks and unwilling to stop
- Previous participation in this study phase or feasibility phase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 days
Participants complete up to 9 days of supportive care and daily symptom diaries while their symptoms are monitored before potential randomization.
Daily symptom diary entries and periodic follow-ups on Days 1, 3, 5, 7, 10, and 14
Duration - 14 days
Participants who do not improve during the waiting period or meet criteria are randomly assigned to receive one of four interventions involving antibiotics and/or intranasal corticosteroids for 14 days.
Daily symptom diary entries and assessments on Days 1, 7, and 14
Trial Site Locations
Total: 7 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
3
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
Not Yet Recruiting
4
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
5
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
6
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
7
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
L
Lead Project Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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