A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
Phase 2
Completed
- Conditions
- Otitis Media
- Registration Number
- NCT00276042
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
Inclusion Criteria
- Acute Otis Media
Exclusion Criteria
- Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate bacteriologic efficacy
- Secondary Outcome Measures
Name Time Method To describe investigator assessment of clinical response
Trial Locations
- Locations (1)
Local Institution
🇮🇱Beer Sheva, Israel