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

Summary

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.

Conditions

• Sinus Infection
• Acute Sinusitis

Interventions

DRUG

amoxicillin/clavulanate potassium

Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days

DRUG

Placebo

Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days

DRUG

Budesonide nasal spray

Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• Penn State College of Medicine

  collaborator UNKNOWN

• Daniel Merenstein

  lead OTHER

Principal Investigators

• Dan Merenstein, MD · Georgetown University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-21

Primary Completion

2028-10-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations