Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-27 @ 12:52 PM
Study NCT ID:
NCT01552668
Status:
WITHDRAWN
Last Update Posted:
2014-05-28
First Post:
2012-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fidaxomicin to Prevent Clostridium Difficile Colonization
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
The Effect of a Twice Daily, 200 mg Dose of Oral Fidaxomicin Compared to Placebo on Risk of Acquiring C. Difficile and Developing C. Difficile Infection (CDI) in High Risk Patients
Status:
WITHDRAWN
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not performed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.
Detailed Description:
A novel approach to prevent C. difficile infection is to use compounds with activity against C. difficile as primary prophylaxis in high risk patients. Chemoprophylaxis theoretically can prevent C. difficile infection by two mechanisms. It may reduce transmission from asymptomatic C. difficile carriers by reducing the number of spores shed in the stool and prevent replication and subsequent toxin production of the organisms in patients at risk for C. difficile infection.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U54CK000162 | NIH | None | https://reporter.nih.gov/quic… | View |