Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132938
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-08-18
Brief Title:
PERSPECTIVE Telithromycin - Acute Exacerbation of Chronic Bronchitis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Open-label Randomized Multicenter Clinical Study to Compare the Effects of Telithromycin Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis
Status:
COMPLETED
Status Verified Date:
2011-06
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 Objective
The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae Sp strains resistant to beta-lactams or macrolides at the Test of Cure TOC visit in the sputum of patients with Sp detected at the start of the study Visit 1
Secondary Objectives
The secondary objectives of the study are
To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study Visit 1
To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp PERSp population with the cure rates in the sensitive Sp SSp population at the End of Therapy EOT and Test of Cure visits
To compare the effect of telithromycin azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study Visit 1
To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin azithromycin and cefuroxime axetil in the global randomized population
The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae Sp strains resistant to beta-lactams or macrolides at the Test of Cure TOC visit in the sputum of patients with Sp detected at the start of the study Visit 1
Secondary Objectives
The secondary objectives of the study are
To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study Visit 1
To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp PERSp population with the cure rates in the sensitive Sp SSp population at the End of Therapy EOT and Test of Cure visits
To compare the effect of telithromycin azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study Visit 1
To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin azithromycin and cefuroxime axetil in the global randomized population
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 |
|---|---|---|---|
| EudraCT 2004-001412-30 | None | None | None |