Overview

Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance

Status:
Terminated
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Alejandro Hoberman
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
Clavulanic Acid
Clavulanic Acids