Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?

  • STATUS
    Recruiting
  • End date
    Sep 29, 2022
  • participants needed
    688
  • sponsor
    Nader Shaikh
Updated on 23 February 2022
antibiotic therapy
antibiotics
amoxicillin-clavulanate
amoxicillin
rhinosinusitis
amoxicillin-clavulanic acid
acute sinusitis
sinusitis

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.

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.

Details
Condition Sinusitis, Respiratory Tract Infections
Treatment Placebo, Amoxicillin-clavulanate
Clinical Study IdentifierNCT02554383
SponsorNader Shaikh
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Meets criteria for "persistent" or "worsening" presentations of sinusitis
Baseline score 9 on the Pediatric Rhinosinusitis Symptom Scale

Exclusion Criteria

Severe presentation (3 days of colored nasal discharge and fever 39C
Asthma/allergic rhinitis explains symptoms
Allergy to amoxicillin-clavulanate
Immotile cilia syndrome
Cystic fibrosis
Immunodeficiency
Parental inability to read/write English or Spanish
Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal pharyngitis)
Systemic toxicity
Wheezing on exam
Antibiotic use within 15 days
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