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

Acute Sinusitis Clinical Trial

Official title: Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis - Pilot

Status Active, not recruiting

Clinical Trial Summary

Sinus infections are sometimes treated with antibiotics or nasal 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. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

Clinical Trial Description

One in seven adults are diagnosed with acute sinus infections (also known as rhinosinusitis or ARS) every year in the United States, for an annual total of 30 million office visits. Most acute sinus infections seen in outpatient setting are caused by viral infection, but antibiotics are prescribed in over 70% of these visits. The overarching goal is to improve outcomes for patients with ARS by understanding which subgroups are most likely to benefit from antibiotics, supportive care, watchful waiting, intranasal corticosteroids (INCS), or a combination of treatments. To assess the comparative effectiveness of the treatments, a large, pragmatic, randomized controlled trial, will be conducted in practice-based research networks within six geographical areas. Enrolled adults ages 18-65 years presenting to a clinician with symptoms consistent with ARS for less than 10 days will begin with a pre-randomization period with options for supportive care. Patients who reached more than 9 days of symptoms at the time of enrollment or during the waiting period will be randomly assigned to one of the four treatment arms. In preparation for the full-scale trial, a smaller feasibility study of the protocol will be piloted in a subset of clinics within the same research networks. ;

Related Conditions & MeSH terms

• Acute Sinusitis
• Sinus Infection
• Sinusitis

• NCT number: NCT06076304
• Study type: Interventional
• Source: Georgetown University
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 21, 2023
• Completion date: May 2024