NCT01511107

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

A Phase 2b, Multicenter, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Short-Course Antimicrobial Therapy for Young Children With Acute Otitis Media (AOM) and Impact on Antimicrobial Resistance

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Alejandro Hoberman · Academic / Other
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Media

Interventions

Type	Name	Description
DRUG	Amoxicillin-Clavulanate, 10 days	Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-10
DRUG	Amoxicillin-Clavulanate, 5 days	Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-5 Plus Placebo Days 6-10

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2012-01-18
• Last updated: 2017-10-06
• Results posted: 2017-02-10

Locations

2 sites across 1 country: United States