The Pittsburgh Study
We recently completed a double-blind, randomized, placebo-controlled clinical trial designed to address uncertainty concerning the relative merits of prompt antimicrobial treatment in young children with AOM, when compared with expectant management in which antimicrobial treatment is reserved for those children deemed not to be responding satisfactorily. Certain of the needed advance decisions regarding trial design were easy and straightforward. We limited enrollment to otherwise healthy children younger than 2 years because it is in that age group that AOM occurs most commonly and also is most resistant to treatment. We used stringent criteria for the diagnosis of AOM, requiring the presence of middle-ear effusion and bulging of the tympanic membrane (TM), because any effects of treatment would best be demonstrated in children whose diagnosis of AOM initially had been quite certain. We chose high-dose amoxicillin-clavulanate, administered for 10 days, as our active drug because in previous studies in children with AOM it had proven the most effective of the available orally administered antimicrobials. We advised all parents to administer acetaminophen as needed for relief of symptoms.
Less straightforward, however, were the advance decisions we needed to make about outcome measures, and about which of the measures should be designated as primary. The 2 outcomes of principal interest to us were resolution of infection and abatement of symptoms.
Pediatr Infect Dis J. 2013;32(7):745-747. © 2013
Lippincott Williams & Wilkins