Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media

Sanofi56 enrolled

Overview

The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM). Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Otitis Media

Interventions

Telithromycin (HMR3647)DRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are weighing 40 kg or less. If female, premenarchal status is required. * Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Sanofi-Aventis

Tokyo, Japan

Outcomes

Primary Outcomes

Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings

Secondary Outcomes

Clinical efficacy: tympanic signs

Acceptability: compliance and willingness to take medication

Pharmacokinetics: plasma concentrations of telithromycin

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.