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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: January 10, 2006
Last updated: February 1, 2008
Last verified: February 2008
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

Condition Intervention Phase
Otitis Media
Drug: Faropenem Medoxomil
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Replidyne:

Primary Outcome Measures:
  • To evaluate bacteriologic efficacy

Secondary Outcome Measures:
  • To describe investigator assessment of clinical response

Enrollment: 328
Study Start Date: January 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed 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.

Ages Eligible for Study:   6 Months to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute Otis Media

Exclusion Criteria:

  • Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276042

Costa Rica
Local Institution
San Jose, Costa Rica
Local Institution
Beer Sheva, Israel
Sponsors and Collaborators
Study Director: Roger M Echols, MD Replidyne, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00276042     History of Changes
Other Study ID Numbers: REP-FAR-008 
Study First Received: January 10, 2006
Last Updated: February 1, 2008
Health Authority: Costa Rica: CONIS
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Replidyne:

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2016