Skip to main content
OpenTrials
Completed

NCT Number: NCT00276042

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, San José, Costa Rica

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute Otis Media

Exclusion criteria

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

Treatment and study plan

Faropenem Medoxomil

Drug

Primary outcomes

  1. To evaluate bacteriologic efficacy

Secondary outcomes

  1. To describe investigator assessment of clinical response

Sponsors and collaborators

Lead sponsor

Replidyne

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 12, 2006
Registry last updated
Feb 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.