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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276042

Enrollment

328

Registered

2006-01-12

Start date

2006-01-31

Completion date

Unknown

Last updated

2008-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

AOM

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.

Interventions

DRUGFaropenem Medoxomil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Months to 7 Years

Healthy volunteers

Inclusion criteria

* Acute Otis Media

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate bacteriologic efficacy	—

Secondary

Measure	Time frame
To describe investigator assessment of clinical response	—

Countries

Costa Rica, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026