Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Condition: Sinusitis; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Sinusitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to determine whether certain subgroups of children with acute
      sinusitis exist in whom antibiotic therapy can be appropriately withheld.
    

Detailed description: 
      The current clinical practice guideline from the American Academy of Pediatrics for the
      Diagnosis and Management of Acute Bacterial Sinusitis recommends that the diagnosis of acute
      sinusitis is made when symptoms of an upper respiratory infection (URI) persist beyond 10
      days without showing signs of improvement (persistent presentation), when symptoms appear to
      worsen (on the 6th to 10th day) after a period of improvement (worsening presentation), or
      when both high fever and purulent nasal discharge are present concurrently for at least 3
      consecutive days (severe presentation). In studies to date, children with persistent and
      worsening presentations comprise >95% of cases. The investigators preliminary data and the
      available literature suggest that only a subset of children being diagnosed with acute
      sinusitis on the basis of current criteria are likely to have bacterial disease. This is not
      entirely surprising because current criteria rely solely on the duration and the quality of
      respiratory tract symptoms (which are both common and non-specific). Accordingly, it seems
      likely that many children currently being diagnosed as having acute sinusitis actually have
      an uncomplicated upper respiratory infection. This is important because acute sinusitis is
      one of the most common diagnoses for which antimicrobials are prescribed for children in the
      United States, accounting for 7.9 million prescriptions annually. A critical need thus exists
      to establish which subgroups of children currently being diagnosed with acute sinusitis
      actually benefit from antimicrobial therapy.

      The objective of this trial is to determine whether certain subgroups of children with acute
      sinusitis exist in whom antibiotic therapy can be appropriately withheld. This objective will
      be achieved by conducting a large, randomized, double-blind, placebo-controlled clinical
      trial in children 2 to 12 years of age with persistent or worsening presentations of acute
      sinusitis. Based on the investigators preliminary data, the investigators hypothesize that
      only certain subgroups of children currently being treated for acute sinusitis actually
      benefit from antimicrobial therapy. By identifying, in a large placebo-controlled trial,
      subgroups of children who respectively do and do not benefit from antimicrobial therapy, the
      investigators will be better able to determine which children should be classified as having
      acute bacterial sinusitis. Accordingly, the results of this trial may impact not only the
      treatment guidelines for acute sinusitis but also the diagnostic criteria, and will help
      ensure that, to the extent possible, antibiotic use is limited to appropriate patients. This,
      in turn, will maximize the likelihood of achieving optimal outcomes and minimize the risk of
      promoting antibiotic resistance.
    

Intervention name(s): Amoxicillin-clavulanate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days); placebo made to match the study antibiotic given twice a day orally for 10 days
Other intervention name(s): Augmentin-Extra strength
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; antibiotics; placebo