NCT00276042

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

February 8, 2008

Status Verified

February 1, 2008

Enrollment Period

1 year

First QC Date

January 10, 2006

Last Update Submit

February 1, 2008

Conditions

Otitis Media

Keywords

AOM

Outcome Measures

Primary Outcomes (1)

  • To evaluate bacteriologic efficacy

Secondary Outcomes (1)

  • To describe investigator assessment of clinical response

Interventions

Faropenem MedoxomilDRUG

Eligibility Criteria

Age6 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Acute Otis Media

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

San José, Costa Rica

Location

Local Institution

Beersheba, Israel

Location

MeSH Terms

Conditions

Otitis Media

Interventions

faropenem medoxomil

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Roger M Echols, MD

    Replidyne, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Last Updated

February 8, 2008

Record last verified: 2008-02

Locations

CO(1)IL(1)