RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-21
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06076304

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-75 years old; AND are experiencing either:
  2. 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. 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'').
  1. * allergy or intolerance to penicillin
  2. * received systemic antibiotic therapy in the past 4 weeks
  3. * prior sinus surgery (cosmetic surgery, such as rhinoplasty, septal deviation, etc. are not exclusionary)
  4. * complications of sinusitis (facial edema (swelling), cellulitis), or orbital, meningeal or cerebral signs)
  5. * health care clinician determined IV (intravenous) antibiotics or hospital admission are required
  6. * pregnancy or breastfeeding
  7. * presence of a comorbidity or medication that may impair a patient's immune response as determined by a health care clinician
  8. * hospitalization in past 5 days
  9. * unable or unwilling to provide informed consent or comply with study protocol requirements
  10. * fever \>39°C or 102°F today
  11. * taking intranasal corticosteroids (INCS) regularly in the past two weeks and unwilling to stop its use while in the study; OR
  12. * previously enrolled or participated in the feasibility phase or this stage of study

Contacts and Locations

Study Contact

Lead Project Coordinator
CONTACT
202-687-6454
researchfammed@georgetown.edu

Principal Investigator

Dan Merenstein, MD
PRINCIPAL_INVESTIGATOR
Georgetown University

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
MedStar Health Research Institute
Hyattsville, Maryland, 20782
United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States
University of Washington
Seattle, Washington, 98195
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Daniel Merenstein

  • Dan Merenstein, MD, PRINCIPAL_INVESTIGATOR, Georgetown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-11-21
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • sinusitis
  • antibiotics
  • intranasal corticosteroids
  • saline nasal irrigation
  • comparative effectiveness

Additional Relevant MeSH Terms

  • Sinus Infection
  • Acute Sinusitis