RecruitingPhase 4

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

United States3,720 participantsStarted 2023-11-21

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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'').

What they're measuring

Symptom Improvement

Timeframe: Change from Day 1 to Day 3 in Phase 2; differences in longitudinal trends across groups during Phase 2

Trial details

NCT IDNCT06076304

SponsorDaniel Merenstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Lead Project Coordinator

202-687-6454 researchfammed@georgetown.edu

View on ClinicalTrials.gov More Sinus Infection trials