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Antibiotic

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

NOSES 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.Check my eligibility

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.See study design

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.

NOSES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

NOSES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 days of symptoms, and 1, 7, and 14 days post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9 days of symptoms, and 1, 7, and 14 days post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 days of symptoms, and 1, 7, and 14 days post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Adverse events

Global Rating of Improvement

Improvement of symptoms

+2 more

Other outcome measures

Adherence

C-reactive protein (CRP)

Saline nasal irrigation

+1 more

NOSES Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: placebo antibiotic plus intranasal corticosteroidExperimental Treatment4 Interventions

placebo antibiotic plus budesonide

Group II: antibioticActive Control3 Interventions

amoxicillin/clavulanate

Group III: antibiotic plus intranasal corticosteroidActive Control4 Interventions

amoxicillin/clavulanate plus budesonide

Group IV: placebo antibioticPlacebo Group3 Interventions

placebo antibiotic

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Budesonide nasal spray

2014

Completed Phase 3

~200

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonOTHER

1,182 Previous Clinical Trials

3,167,243 Total Patients Enrolled

3 Trials studying Sinusitis

461 Patients Enrolled for Sinusitis

University of California, Los AngelesOTHER

1,528 Previous Clinical Trials

10,276,707 Total Patients Enrolled

2 Trials studying Sinusitis

22 Patients Enrolled for Sinusitis

University of WashingtonOTHER

1,738 Previous Clinical Trials

1,844,207 Total Patients Enrolled

4 Trials studying Sinusitis

119 Patients Enrolled for Sinusitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its blessing to antibiotics?

"Having completed Phase 4, the highest level of clinical trials, antibiotic has been established as safe and is thus given a score of 3."

Answered by AI

Is this research endeavor available to adults of advanced years?

"Those wishing to join this clinical trial must be 18-65 years old. For minors and seniors, there are 3 studies addressing their needs specifically with a total of 55 participants."

Answered by AI

Who is eligible to join this research program?

"To be considered for inclusion in this research, potential participants must have sinusitis and fall between the ages of 18 to 65. The total number of candidates being accepted is 144."

Answered by AI

How many locations are participating in the trial's execution?

"This research study is being conducted from 8 different locations, including Georgetown University Medical Center in Washington D.C., MedStar Health Research Institute in Hyattsville, Maryland and Virginia Commonwealth University based out of Richmond, Virginia."

Answered by AI

Is enrollment for this experimental research still taking place?

"According to current clinicaltrials.gov data, this medical trial is not currently accepting patients for enrollment. Initially posted on December 1st 2023 and updated as recently as October 3rd of the same year, there are 57 other studies actively recruiting in its place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Daniel Merenstein 2023. "Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis - Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06076304.

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