A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media

Replidyne328 enrolled

Overview

The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem

The study will be conducted in infants and children with acute otitis media, 6 months to \<7 years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and complicated AOM.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

328

Conditions

Otitis Media

Interventions

Faropenem MedoxomilDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute Otis Media Exclusion Criteria: * Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment

Locations (2)

Local Institution

San José, Costa Rica

Local Institution

Beersheba, Israel

Outcomes

Primary Outcomes

To evaluate bacteriologic efficacy

Secondary Outcomes

To describe investigator assessment of clinical response

Data from ClinicalTrials.gov

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