A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media - Full Text View

Sponsored by:	Replidyne
Information provided by:	Replidyne
ClinicalTrials.gov Identifier:	NCT00276042

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Fropenem Faropenem medoxomil

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
Estimated Study Completion Date:	May 2007
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

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

Keywords provided by Replidyne:

AOM

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

ClinicalTrials.gov processed this record on September 11, 2009