Guidelines for Acute Sinusitis

NCT00132275 | Completed

• 2 other identifiers: 1000928Thrasher Award No 02818-4
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Keywords

bacterial; sinusitis; treatment; diagnosis; guideline; acute bacterial sinusitis

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• Proportion of children who are cured at 72 hours in each group

• Proportion of children who fail therapy in each group

• Proportion of children who develop adverse events

Interventions

Amoxicillin potassium clavulanate DRUG

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

University of Pittsburgh/Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• American Academy of Pediatrics. Subcommittee on Management of Sinusitis and Committee on Quality Improvement. Clinical practice guideline: management of sinusitis. Pediatrics. 2001 Sep;108(3):798-808. doi: 10.1542/peds.108.3.798.

  PMID: 11533355 BACKGROUND

• Wald ER, Nash D, Eickhoff J. Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. Pediatrics. 2009 Jul;124(1):9-15. doi: 10.1542/peds.2008-2902.

  PMID: 19564277 DERIVED

MeSH Terms

Conditions

Sinusitis; Disease

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ellen R Wald, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: November 1, 2003
• Study Completion: August 1, 2006
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

US (1)