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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00276042
First Posted: January 12, 2006
Last Update Posted: February 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Replidyne
  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
Intervention Model: Parallel Assignment
Masking: Double
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00276042     History of Changes
Other Study ID Numbers: REP-FAR-008
First Submitted: January 10, 2006
First Posted: January 12, 2006
Last Update Posted: February 8, 2008
Last Verified: February 2008

Keywords provided by Replidyne:
AOM

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents