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Guidelines for Acute Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00132275
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : May 20, 2008
Thrasher Research Fund
Information provided by:
University of Pittsburgh

Brief Summary:

Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are, for the most part, self-limited episodes that resolve spontaneously and do not require antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent complications of viral upper respiratory infections that will benefit from treatment with antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory practice and, in all age groups, accounts for an estimated 25 million physician office visits annually. It is essential to distinguish between patients who are experiencing uncomplicated viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use of antibiotics for patients who will not benefit from them. This is especially important now because of the escalation of antibiotic resistance among the bacteria that commonly cause acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics is a major contributor to the problem of antimicrobial resistance - a problem which dramatically increases both the cost and complexity of treatment.

To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed by three national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is confirmed with the performance of images (either plain radiographs, computed tomography or magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria alone without the confirmation of imaging or other laboratory data. Although the similarity between the different guidelines suggests that there is widespread consensus to use clinical criteria to diagnose acute bacterial sinusitis, there is virtually no evidence to support this position. Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A randomized, placebo-controlled study design will be used to determine if the clinical criteria proposed by the different guidelines can be used to identify children with upper respiratory symptoms who will respond to antibiotic therapy. It is expected that children with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and more often than children who receive placebo.

Condition or disease Intervention/treatment Phase
Sinusitis Drug: Amoxicillin potassium clavulanate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of National Guidelines for Acute Sinusitis
Study Start Date : November 2003
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium Sinusitis
Drug Information available for: Amoxicillin

Primary Outcome Measures :
  1. A comparison of the proportion of children who have a complete resolution (cure) of their respiratory symptoms in each treatment group (Amoxicillin clavulanate versus placebo)

Secondary Outcome Measures :
  1. Proportion of children who are cured at 72 hours in each group
  2. Proportion of children who fail therapy in each group
  3. Proportion of children who develop adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

A convenience sample of children between 1 and 10 years of age with one of three clinical presentations:

  • Onset with persistent symptoms
  • Onset with severe symptoms
  • Onset with worsening symptoms

Exclusion Criteria:

Patients will be excluded if they have:

  • Received antibiotics within 15 days of the onset of respiratory symptoms
  • Had symptoms for > 30 days
  • Have concurrent bacterial infections
  • Are allergic to penicillin
  • Have symptoms that suggest a complication due to acute sinusitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00132275

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United States, Pennsylvania
University of Pittsburgh/Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Thrasher Research Fund
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Principal Investigator: Ellen R Wald, MD University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00132275    
Other Study ID Numbers: 1000928
Thrasher Award No 02818-4
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
Keywords provided by University of Pittsburgh:
acute bacterial sinusitis
Additional relevant MeSH terms:
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Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Clavulanic Acid
Clavulanic Acids
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action