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

NCT ID: NCT00276042

Last Updated: 2008-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Faropenem Medoxomil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute Otis Media

Exclusion Criteria

* Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
Minimum Eligible Age

6 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Replidyne

INDUSTRY

Sponsor Role lead

Principal Investigators

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Roger M Echols, MD

Role: STUDY_DIRECTOR

Replidyne, Inc.

Locations

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Local Institution

San José, , Costa Rica

Site Status

Local Institution

Beersheba, , Israel

Site Status

Countries

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Costa Rica Israel

Other Identifiers

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REP-FAR-008

Identifier Type: -

Identifier Source: org_study_id

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