A Trial to Evaluate Faropenem Medoxomil in the Treatment... | NCT00276042

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

NCT00276042

Sponsor

Replidyne

Status

Completed

Last Update Posted

Feb 8, 2008Estimated

Enrollment

328Actual

Phase

Phase 2

Conditions

Otitis Media

Interventions

Faropenem Medoxomil

Countries

Costa Rica
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Not provided

First Submitted Date

Jan 10, 2006

First Submission Date that Met QC Criteria

Jan 10, 2006

First Posted Date

Jan 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2008

Last Update Posted Date

Feb 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

328Actual

Name	Type	Description	Arm Group Labels	Other Names
Faropenem Medoxomil	Drug

Measure	Description	Time Frame
To evaluate bacteriologic efficacy

Measure	Description	Time Frame
To describe investigator assessment of clinical response

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roger M Echols, MD	Replidyne, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		San José			Costa Rica
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media

Ancestor Terms

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C528565	faropenem medoxomil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided