Treatment Strategies for Sinus Infection (NOSES Trial)

Phase 4

Waitlist Available

Led By Dan Merenstein, MD

Research Sponsored by Daniel Merenstein

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-65 years old and experiencing ongoing symptoms or signs that suggest an acute sinus infection lasting for 1-21 days, without any clinical improvement

Be older than 18 years old

Must not have

Health care clinician determined IV (intravenous) antibiotics or hospital admission are required

Fever >39°C or 102°F

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is studying which treatment works best for sinus infections: antibiotics/nasal sprays, over-the-counter remedies, or supportive care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include irritation or dryness in the nose from Budesonide spray and digestive issues like diarrhea or nausea from Amoxicillin/clavulanate. Placebos typically have no active ingredients but can cause perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had a fever over 102°F recently.

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I have had surgery on my sinuses before.

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I have complications from sinusitis, like swelling or infection around my eyes or brain.

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I have been hospitalized within the last 5 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 days of symptoms, and 3, 7, and 14 days post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9 days of symptoms, and 3, 7, and 14 days post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 days of symptoms, and 3, 7, and 14 days post-randomization for reporting.