Back to resultsA Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
Primary Purpose
Otitis Media
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Faropenem Medoxomil
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring AOM
Eligibility 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
Sites / Locations
- Local Institution
- Local Institution
Outcomes
Primary Outcome Measures
To evaluate bacteriologic efficacy
Secondary Outcome Measures
To describe investigator assessment of clinical response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00276042
Brief Title
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
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 Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Replidyne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
AOM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
328 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Faropenem Medoxomil
Primary Outcome Measure Information:
Title
To evaluate bacteriologic efficacy
Secondary Outcome Measure Information:
Title
To describe investigator assessment of clinical response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger M Echols, MD
Organizational Affiliation
Replidyne, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
San Jose
Country
Costa Rica
Facility Name
Local Institution
City
Beer Sheva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
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