Evaluation of National Guidelines for Acute Sinusitis

Context: Bacterial infections of the paranasal sinuses are an important cause of morbidity in children. However, these infections may be difficult to distinguish from viral upper respiratory infections. Consequently, children with viral upper respiratory infections are frequently treated with antibiotics. The inappropriate use of antibiotics for viral upper respiratory infections is costly and has been responsible, at least in part, for the emergence of antibiotic resistance. To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed. Three national organizations have recently published different guidelines for the diagnosis and treatment of acute bacterial sinusitis: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria 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.

Objectives: The objectives of this study are:

1. to determine the effectiveness of antibiotic treatment of children diagnosed to have acute sinusitis on clinical grounds alone without the performance of sinus images and
2. to evaluate the response to antibiotic therapy or placebo in terms of financial cost to the insurers, patient and family.

Setting and Participants: The study, employing a prospective, randomized, and double blind design will be conducted in three primary care facilities serving a diverse racial and socioeconomic population. Children will be eligible for the study if they are between the ages of 1 and 10 years and present with one of three clinical presentations. Group 1 will be comprised of subjects with persistent disease defined as nasal discharge (of any quality) or daytime cough (which may be worse at night) or both persisting for more than 10 days without evidence of improvement; Group 2 will be patients with non-persistent disease consisting of two subsets: children with nasal discharge or daytime cough that is worsening either on or after the 6th day (> 120 hours) of symptoms [worsening is manifest by the new onset of documented fever (temperature > 100.5o F ) or substantial increase in nasal discharge or cough] and children with severe disease defined as a documented temperature of at least 102o F and purulent (thick, colored and opaque) nasal discharge present concurrently for at least 3 consecutive days (68-72 hours).

Main Outcome Measure: Will be a comparison of the proportion of children who have a complete resolution (cure) of their respiratory symptoms in each of the treatment groups (amoxicillin potassium clavulanate and placebo). Secondary outcome measures will include the proportion of children in each treatment group who: