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NCT00276042 Clinical Trial

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

Otitis Media Clinical Trial

Official title:
Prospective, Randomized, Investigator-Blind Trial to Evaluate the Bacteriologic Eradication, Safety and Tolerability, and Pharmacokinetics of Different Dosages of Faropenem Medoxomil BID for 10 Days in the Treatment of Acute Otitis Media

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00276042
Other study ID # REP-FAR-008
Secondary ID
Status Completed
Phase Phase 2
First received January 10, 2006
Last updated February 1, 2008
Start date January 2006

Study information
Verified date February 2008
Source Replidyne
Contact n/a
Is FDA regulated No
Health authority Costa Rica: CONISIsrael: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 328
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 7 Years
Eligibility Inclusion Criteria:

- Acute Otis Media

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Faropenem Medoxomil

Locations
Country Name City State
Costa Rica Local Institution San Jose
Israel Local Institution Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
Replidyne

Countries where clinical trial is conducted

Costa Rica,  Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate bacteriologic efficacy
Secondary To describe investigator assessment of clinical response
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