RECRUITING

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

Description

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.

Conditions

Sinus InfectionAcute Sinusitis
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Related Conditions:

Sinus InfectionAcute Sinusitis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Sinus Infection
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Washington

Georgetown University Medical Center, Washington, District of Columbia, United States, 20007

Hyattsville

MedStar Health Research Institute, Hyattsville, Maryland, United States, 20782

Hershey

Penn State College of Medicine, Hershey, Pennsylvania, United States, 17033

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23219

Seattle

University of Washington, Seattle, Washington, United States, 98195

Madison

University of Wisconsin-Madison, Madison, Wisconsin, United States, 53705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 18-75 years old; AND are experiencing either:
  • 2. "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
  • 3. 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'').
  • * allergy or intolerance to penicillin
  • * received systemic antibiotic therapy in the past 4 weeks
  • * prior sinus surgery (cosmetic surgery, such as rhinoplasty, septal deviation, etc. are not exclusionary)
  • * complications of sinusitis (facial edema (swelling), cellulitis), or orbital, meningeal or cerebral signs)
  • * health care clinician determined IV (intravenous) antibiotics or hospital admission are required
  • * pregnancy or breastfeeding
  • * presence of a comorbidity or medication that may impair a patient's immune response as determined by a health care clinician
  • * hospitalization in past 5 days
  • * unable or unwilling to provide informed consent or comply with study protocol requirements
  • * fever \>39°C or 102°F today
  • * taking intranasal corticosteroids (INCS) regularly in the past two weeks and unwilling to stop its use while in the study; OR
  • * previously enrolled or participated in the feasibility phase or this stage of study

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Daniel Merenstein,

Dan Merenstein, MD, PRINCIPAL_INVESTIGATOR, Georgetown University

Study Record Dates

2028-12