Project Summary

Acute rhinosinusitis (ARS) is a leading cause of antibiotic use in primary care settings and antibiotics are prescribed in over 70% of outpatient ARS visits in the United States. In the United States, one in seven adults every year are diagnosed with ARS every year (for a total of 30 million office visits), resulting in one in five adults being prescribed antibiotics. However, most patients do not benefit from antibiotics as their symptoms are caused by a viral infection.

In addition to antibiotics, nasal sprays such as intranasal corticosteroids (INCS), over-the-counter supportive treatment, or saline nasal irrigation (SNI) may help improve symptoms. The project team’s goal is to improve outcomes for patients with ARS by understanding for whom antibiotics, INCS, supportive care, or watchful waiting are most likely to provide benefit. The project team hopes the information learned in this study can be used by providers and patients to figure out what is the best way to treat a patient’s ARS. The project team has three major aims and four study groups:

AIM 1: To compare, through patient-reported outcomes, the efficacy of oral antibiotics (amoxicillin-clavulanate) and INCS for clinical improvement of ARS among patients who do not improve with supportive care alone.

AIM 2: To identify which patient subgroups benefit most from oral antibiotics versus INCS, based on baseline patient and disease characteristics.

AIM 3: To identify which patient subgroups improve with supportive care, and do not require antibiotics or INCS. Patients may also use over-the-counter supportive treatment and/or SNI anytime during the study.

Study Groups: Patients who reach day 10 of ARS symptoms will be randomly assigned to one of four groups: Group 1. antibiotics; Group 2. placebo antibiotics plus INCS; Group 3. antibiotics plus INCS; and Group 4. placebo antibiotic. All groups will have options for symptomatic care and SNI.

Patients will be recruited from primary care offices in six regions across the United States. Approximately 3,720 patients will enroll in this study. To qualify, patients must be 18-65 years old, diagnosed with ARS, and in reasonably good health aside from their ARS symptoms. The primary outcome will be the effect of the different treatments on the participant’s quality of life. The project team will use a survey that has been studied for ARS which measures issues and symptoms that are most important to patients. The project team will assess outcomes before patients have started any antibiotics and/or INCS, and 3, 7, 10, 14 and 21 days after. Secondary outcomes are illness duration, treatment failure, having to visit a provider again for the same symptoms, missed work, and adverse events. Additional secondary outcomes, questions, or data points recommended by the focus groups, Patient Advisory Committee (PAB), or other committees, will be added during the feasibility phase.

At the present time the project team sees the stakeholders as patients, caregivers, community members, primary care providers, specialists (e.g. in otolaryngology (ENT) or infectious diseases), nonprofits and foundations involved in antimicrobial stewardship, ABIM Foundation Choosing Wisely® Initiative, Alliance for the Prudent Use of Antibiotics, The Pew Charitable Trusts, Asthma and Allergy Foundation, Public Health Foundation, clinical societies (with known interest in antibiotic stewardship) such as the American Academy of Family Physicians, American College of Physicians, American Society of Consultant Pharmacists, American Society for Microbiology, Society for Healthcare Epidemiology of America, and the CDC. The project team plans on adding additional stakeholders after consultations with the PAB, focus groups and other committees during the feasibility phase.

Project Information

Daniel Merenstein, MD
Georgetown University Medical Center
$23,602,115 *

Key Dates

66 months *
2022

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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Last updated: August 5, 2022