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

This study has been completed.
Sponsor:
Information provided by:
Replidyne
ClinicalTrials.gov Identifier:
NCT00276042
First received: January 10, 2006
Last updated: February 1, 2008
Last verified: February 2008
History of Changes
  Purpose

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:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

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.

  Eligibility

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

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

Locations
Costa Rica
Local Institution
San Jose, Costa Rica
Israel
Local Institution
Beer Sheva, Israel
Sponsors and Collaborators
Replidyne
Investigators
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:
AOM

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

ClinicalTrials.gov processed this record on June 18, 2013