Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261105
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2005-12-01
Brief Title:
Telithromycin in Respiratory Tract Infections
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Open Multicenter Non-comparative Phase IV Trial of Efficacy and Safety of KetekTelithromycin 800mg
Status:
COMPLETED
Status Verified Date:
2009-09
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:
Primary Objectives
The primary objective of the study is to evaluate clinical efficacy ie to show that with respect to clinical cure rate Ketek telithromycin in the treatment of community acquired respiratory tract infections community acquired pneumonia CAP acute bacterial exacerbation of chronic bronchitis AECB and acute sinusitis AS in outpatients
Secondary Objectives
The secondary objectives are to
Further assess the efficacy of Ketek telithromycin by considering the rate at which additional antibacterials were prescribed to treat the primary infection the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data chest X-ray and sinus X-ray if available
Evaluate safety of Ketek telithromycin through Adverse Event AE and Serious Adverse Event SAE reporting
The primary objective of the study is to evaluate clinical efficacy ie to show that with respect to clinical cure rate Ketek telithromycin in the treatment of community acquired respiratory tract infections community acquired pneumonia CAP acute bacterial exacerbation of chronic bronchitis AECB and acute sinusitis AS in outpatients
Secondary Objectives
The secondary objectives are to
Further assess the efficacy of Ketek telithromycin by considering the rate at which additional antibacterials were prescribed to treat the primary infection the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data chest X-ray and sinus X-ray if available
Evaluate safety of Ketek telithromycin through Adverse Event AE and Serious Adverse Event SAE reporting
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