Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDaniel Merenstein
About this trial
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.
Eligibility criteria
Qualifiers
"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'').
Disqualifiers
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)
Trial design
Treatments tested in this trial
- amoxicillin/clavulanate potassium
- Placebo
- Budesonide nasal spray
Treatment groups
3,720 Participants
are divided into 4 treatment groupsSponsors and collaborators
Daniel Merenstein
Lead sponsor
Georgetown University
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator
Medstar Health Research Institute
Collaborator
University of Washington
Collaborator
Virginia Commonwealth University
Collaborator
University of California, Los Angeles
Collaborator
University of Wisconsin, Madison
Collaborator
Penn State College of Medicine
Collaborator
Source ClinicalTrials.gov