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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Otitis Media

Treatments: Drug: Telithromycin (HMR3647)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638534

EFC6370

HMR3647B/3103

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 6 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)