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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
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 belowSelect...
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:Select...
I need IV antibiotics or must be admitted to the hospital.
Select...
I have had a fever over 102°F recently.
Select...
I have had surgery on my sinuses before.
Select...
I have complications from sinusitis, like swelling or infection around my eyes or brain.
Select...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Adverse events
Global Rating of Improvement
Improvement of symptoms
+2 moreOther study objectives
Adherence
C-reactive protein (CRP)
Saline nasal irrigation
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
University of California, Los AngelesOTHER
1,569 Previous Clinical Trials
10,310,569 Total Patients Enrolled
University of WashingtonOTHER
1,831 Previous Clinical Trials
1,903,849 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,237 Previous Clinical Trials
3,197,259 Total Patients Enrolled
Medstar Health Research InstituteOTHER
197 Previous Clinical Trials
182,351 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,101,539 Total Patients Enrolled
Daniel MerensteinLead Sponsor
Penn State College of MedicineUNKNOWN
Virginia Commonwealth UniversityOTHER
719 Previous Clinical Trials
22,892,116 Total Patients Enrolled
Dan Merenstein, MDPrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
68 Total Patients Enrolled