Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174811
Status:
TERMINATED
Last Update Posted:
2009-04-03
First Post:
2005-09-13
Brief Title:
Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Multinational Randomized Double-Blind Double-Dummy Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mgkg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mgkg Given Twice Daily for 10 Days in Children With Acute Otitis Media
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pediatric development program terminated by sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical activity of telithromycin vs cefuroxime in children with acute infections of the middle ear ages 6 months to 59 months old will be studied
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 |
|---|---|---|---|
| HMR3647B3001 | None | None | None |