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CompletedNCT00276042Updated Feb 8, 2008

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

A Phase 2 interventional study of Faropenem Medoxomil in Otitis Media, sponsored by Replidyne. Completed at 2 sites in 2 countries. Open to participants aged 6 Months to 7 Years. Per ClinicalTrials.gov, last updated 2008-02-08.

Sponsored by Replidyne · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
328
Allocation
Randomized
Ages
6 Months to 7 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Otitis Media

Keywords

  • AOM
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's enrollment of 328 is above the median of 126 across 173 interventional studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Replidyne is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute Otis Media

Exclusion criteria

Exclusion Criteria:

  • Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
328 participants (actual)

Interventions

  • DrugFaropenem Medoxomil
06

What researchers measure

Primary outcomes

  1. To evaluate bacteriologic efficacy

Secondary outcomes

  1. To describe investigator assessment of clinical response

07

Study locations

2 sites
  • Local Institution
    San Jose, Costa Rica
  • Local Institution
    Beer Sheva, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00276042
Lead sponsor
Replidyne
First posted
Jan 12, 2006
Start date
Jan 2006
Primary completion
Jan 2007
Last update
Feb 8, 2008

Study contacts

Roger M Echols, MD
study director · Replidyne, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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