Pneumonia
Conditions
Keywords
Community-Acquired pneumonia, CAP, children, Child
Brief summary
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7 days in children with community-acquired pneumonia (CAP). Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of telithromycin 20 mg/kg qd for 5-7 days in children with CAP.
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 who are diagnosed with CAP based on chest X-ray showing the presence of a new infiltrate, clinical symptoms, and laboratory findings. 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: change in the symptoms and signs | — |
| Acceptability: compliance and willingness to take medication | — |
| Pharmacokinetics: plasma concentrations of telithromycin | — |
Countries
Japan
Outcome results
None listed