Otitis Media
Conditions
Keywords
Acute Otitis Media, AOM, children, Child
Brief summary
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.
Interventions
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy: tympanic signs | — |
| Acceptability: compliance and willingness to take medication | — |
| Pharmacokinetics: plasma concentrations of telithromycin | — |
Countries
Japan
Outcome results
None listed