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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Sinus infections are sometimes treated with oral antibiotics or nasal steroid sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. Sometimes this is enough to help patients wait a few days to see if their infection clears up without needing to use antibiotics or nasal steroid sprays. The overall goal of this clinical trial to see which specific groups of patients benefit more from which intervention or combination of intervention, and which improve with supportive care alone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18-75 years old; AND are experiencing either:

• 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

• 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'').

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Maryland
MedStar Health Research Institute
NOT_YET_RECRUITING
Hyattsville
Pennsylvania
Penn State College of Medicine
RECRUITING
Hershey
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Contact Information
Primary
Lead Project Coordinator
researchfammed@georgetown.edu
202-687-6454
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2028-12
Participants
Target number of participants: 3720
Treatments
Active_comparator: antibiotic
amoxicillin/clavulanate
Placebo_comparator: placebo antibiotic
placebo antibiotic, amoxicillin/clavulanate
Active_comparator: antibiotic plus intranasal corticosteroid
amoxicillin/clavulanate plus budesonide
Other: placebo antibiotic plus intranasal corticosteroid
placebo antibiotic plus budesonide
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, Virginia Commonwealth University, Penn State College of Medicine, University of Wisconsin, Madison, Medstar Health Research Institute, University of California, Los Angeles, Patient-Centered Outcomes Research Institute
Leads: Daniel Merenstein

This content was sourced from clinicaltrials.gov