Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT04003818
Status:
TERMINATED
Last Update Posted:
2025-09-23
First Post:
2019-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Teicoplanin in CDAD
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Prospective, Interventional, Phase IV Study, Evaluating the Efficacy and Safety of Teicoplanin (100-200 mg, Administered Orally Twice a Day) in Patients With Clostridium Difficile Infection-associated Diarrhea and Colitis
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to COVID-19 and great challenges during patient enrolment period, current status of this study is far behind the plan. The study cannot be completed according to the plan. Sanofi decides to terminate the study upon comprehensive assessment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective:
Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis
Secondary Objective:
Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis
Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis
Secondary Objective:
Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis
Detailed Description:
Approximate 10 weeks
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1230-0601 | OTHER | UTN | View |