Trials / Completed
CompletedNCT00276042
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 328 (actual)
- Sponsor
- Replidyne · Industry
- Sex
- All
- Age
- 6 Months – 7 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Faropenem Medoxomil |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2007-01-01
- First posted
- 2006-01-12
- Last updated
- 2008-02-08
Locations
2 sites across 2 countries: Costa Rica, Israel
Source: ClinicalTrials.gov record NCT00276042. Inclusion in this directory is not an endorsement.