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

Replidyne

Status and phase: Completed; Phase 2

Conditions: Otitis Media

Treatments: Drug: Faropenem Medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276042

REP-FAR-008

Details and patient eligibility

About

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

Full description

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.

Enrollment: 328 patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute Otis Media

Exclusion criteria

• Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind