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
• 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. 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

• Otitis
• Otitis Media

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