Treatment Strategies for Sinus Infection
(NOSES Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byDan Merenstein, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Daniel Merenstein

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Sinus infections are sometimes treated with oral antibiotics or nasal steroid 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. Sometimes this is enough to help patients wait a few days to see if their infection clears up without needing to use antibiotics or nasal steroid sprays. The overall goal of this clinical trial to see which specific groups of patients benefit more from which intervention or combination of intervention, and which improve with supportive care alone.

Eligibility Criteria

Adults aged 18-65 with symptoms of a sinus infection lasting 1-21 days without improvement can join. Excluded are those with prior sinus surgery, severe complications, weakened immune systems, recent hospitalization or antibiotic use, penicillin allergy, pregnancy/breastfeeding, and inability to consent or follow the study.

Inclusion Criteria

I am between 18 and 65 years old with symptoms of a sinus infection for 1-21 days without getting better.

Exclusion Criteria

I have taken antibiotics in the last month.

I need IV antibiotics or must be admitted to the hospital.

I have had a fever over 102°F recently.

+9 more

Participant Groups

The trial is testing if nasal steroids (Budesonide), oral antibiotics (Amoxicillin/clavulanate), or placebo treatments help people with sinus infections recover better. It also aims to identify which patients benefit most from each treatment option.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: placebo antibiotic plus intranasal corticosteroidExperimental Treatment3 Interventions

placebo antibiotic plus budesonide

Group II: antibioticActive Control2 Interventions

amoxicillin/clavulanate

Group III: antibiotic plus intranasal corticosteroidActive Control3 Interventions

amoxicillin/clavulanate plus budesonide

Group IV: placebo antibioticPlacebo Group2 Interventions

placebo antibiotic, amoxicillin/clavulanate