Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00638859
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2008-03-12
Brief Title:
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Evaluation of the Safety Pharmacokinetics Efficacy and Acceptability of HMR3647 20 mgkg qd for 5-7 Days With Community-Acquired Pneumonia CAP in Children Multicenter Open Label Noncomparative Study
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to assess the safety of telithromycin HMR3647 20 mgkg qd for 5-7 days in children with community-acquired pneumonia CAP
Secondary objectives are to assess Pharmacokinetics Efficacy and Acceptability of telithromycin 20 mgkg qd for 5-7 days in children with CAP
Secondary objectives are to assess Pharmacokinetics Efficacy and Acceptability of telithromycin 20 mgkg qd for 5-7 days in children with CAP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HMR3647B3101 | None | None | None |