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

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ClinicalTrials.gov Identifier: NCT00276042
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : February 8, 2008
Sponsor:
Information provided by:
Replidyne

Brief 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

Condition or disease Intervention/treatment Phase
Otitis Media Drug: Faropenem Medoxomil Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
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
Study Start Date : January 2006
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections




Primary Outcome Measures :
  1. To evaluate bacteriologic efficacy

Secondary Outcome Measures :
  1. To describe investigator assessment of clinical response


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

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.

ClinicalTrials.gov Identifier: NCT00276042     History of Changes
Other Study ID Numbers: REP-FAR-008
First Posted: January 12, 2006    Key Record Dates
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