Conditions: Acute Otitis Media
Keywords: acute otitis media ear infection antimicrobial therapy antimicrobial resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 520
Healthy volunteers: no

Brief summary:
The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome. This is a Phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with that of consistent standard-duration treatment (10 days) for each episode of AOM developing during a single respiratory season (October 1 through May 31).

Detailed description:
Eligible subjects will be randomized at the enrollment visit and will have a telephone call in the course of therapy, and a subsequent visit at the end of therapy. Thereafter, they will be followed through the end of the respiratory season, and their parents will be encouraged to bring their child when concerned about a potential recurrence of AOM. At each recurrence subjects will receive the treatment regimen (either standard- or reduced-duration) to which they were randomized at study entry (consistent treatment strategy).

The recruitment of eligible children with AOM of varying degrees of severity from various primary care practices in 2 separate geographic regions, i.e. Western Pennsylvania and Kentucky, representing urban, suburban and rural demographics will enhance generalizability of study findings and encourage translation to clinical practice.

Arms:
arm 1: amoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 10 days arm 2: amoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 5 days plus placebo, 2 divided doses, 5 days

Interventions: intervention 1: Amoxicillin-Clavulanate, 10 days intervention 2: Amoxicillin-Clavulanate, 5 days
Intervention descriptions: intervention 1: Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-10 intervention 2: Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-5

Plus

Placebo Days 6-10

Protocol document: