E.W. "Al" Thrasher
Status: Funded - Open
Short (5 days) versus long (14 days) duration of antimicrobial therapy for acute bacterial sinusitis in children
Ellen Wald, M.D.
BACKGROUND: Acute bacterial sinusitis is one of the most common diagnoses in pediatric ambulatory practice and, in all age groups, accounts for an estimated 25 million visits each year. To avoid the unnecessary use of antibiotics in children with uncomplicated viral upper respiratory infections, we have developed stringent criteria for the diagnosis of acute bacterial sinusitis which identifies a subset of children with symptoms of upper respiratory infections that benefit from antimicrobial therapy.
GAP: One issue that has not been studied at all in the pediatric age group is the optimal duration of antibiotic therapy for patients with acute bacterial sinusitis. Short courses of therapy (5 days) are reported to be as effective as long courses (10-14 days) in adults with sinusitis. If effective, short course treatment will reduce the use of antibiotics and may prevent the development of antibiotic resistance in the community.
HYPOTHESIS: We are comparing short course (5 days) to long course (10-14 days) antibiotic therapy for the treatment of acute bacterial sinusitis in children. We hypothesize that short course therapy will lead to more frequent relapses of sinusitis and will not reduce the emergence of resistant nasopharyngeal flora.
METHODS: This will be a prospective, randomized, double-blind study comparing short course (5 days) to long course (15 days) antimicrobial therapy for children between 1 and 10 years of age with acute bacterial sinusitis. The major outcome measure will be the proportion of children with a clinical relapse on day 10 in the short course therapy group compared to day 20 in the long course therapy group. In addition, the proportion of respiratory flora that are resistant to antibiotics on day 30 will be compared to baseline in each group.
DISCUSSION: There is great enthusiasm for short rather than long courses of antimicrobials for bacterial infections in children. However, short course treatment may lead to more frequent relapses (necessitating additional course of treatment) and may not prevent the emergence of resistant respiratory flora. The results of this study will immediately influence treatment strategies in children with acute bacterial sinusitis.
Antibiotics, Drug Resistance, Bacteria, Treatment, Human, Randomized Clinical Trial