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Status:

COMPLETED

Treatment of Acute Sinusitis

Lead Sponsor:

Washington University School of Medicine

Collaborating Sponsors:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Acute Respiratory Infections

Acute Rhinosinusitis

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

Brief Summary

This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infec...

Detailed Description

The primary objective of this phase IV, randomized, placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-re...

Eligibility Criteria

Inclusion

  • The subject must be male or female, and between the ages of 18 and 70 years old.
  • The subject must have symptoms of acute bacterial rhinosinusitis.
  • The subject must be attending a participating primary care practice in the community.
  • The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as moderate, severe, or very severe.
  • The subject must have access to a phone.

Exclusion

  • The subject is less than 18 years old or more than 70 years old.
  • The subject has very mild or mild symptom severity assessed by self report.
  • The subject has an allergy to penicillin or amoxicillin.
  • The subject has received antibiotic therapy within the past 4 weeks (including chronic treatment for acne and low dose prophylactic treatment).
  • The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
  • The subject is thought to require intravenous antibiotics or hospital admission.
  • The subject is pregnant. (This will be assessed by self-report. A pregnancy test will not be required).
  • The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
  • The subject has cystic fibrosis.
  • The subject has Type I diabetes or is taking insulin to treat diabetes.
  • The subject had prior sinus surgery.
  • The subject requires an antibiotic for a concurrent condition such as an ear infection.
  • The subject is not able to complete the study protocol because of language barriers, lack of telephone access, or other issues.
  • Any other condition that the provider feels may interfere with the study.

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

172 Patients enrolled

Trial Details

Trial ID

NCT00377403

Start Date

October 1 2006

End Date

August 1 2010

Last Update

December 28 2012

Active Locations (1)

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1

Washington University in St. Louis

St Louis, Missouri, United States, 63110