Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03105479
Status:
TERMINATED
Last Update Posted:
2019-04-03
First Post:
2017-03-23
Brief Title:
Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea CDAD
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Prospective Multicenter Study to Investigate the Pharmacokinetics Safety and Efficacy of Cadazolid Versus Vancomycin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study suspended in October 2017 and terminated April 17 2018 after decision to discontinue the study drug development
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic cadazolid in the treatment of diarrhea caused by this bacteria This is the first study of cadazolid in children The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile
Detailed Description:
This multicenter study will be run into two parts Both parts will be run in consecutive age cohorts starting from the oldest age categories12 to 18 years old to the youngest birth to 3 months
Part A is an open-label dose finding part to be conducted in at least 24 subjects
Part B follows a randomized assessor-blinded parallel-group design with vancomycin used as an active comparator Part B will be conducted in about 176 children
In both parts the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days
Part A is an open-label dose finding part to be conducted in at least 24 subjects
Part B follows a randomized assessor-blinded parallel-group design with vancomycin used as an active comparator Part B will be conducted in about 176 children
In both parts the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2015-004805-17 | EUDRACT_NUMBER | None | None |