Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536465
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
The Clostridioides Difficile Trial of REC-3964
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Clinical Study of REC-3964 in Adults for the Reduction of Recurrent Clostridioides Difficile Infection CDI
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALDER
Brief Summary:
This is a multi-center open-label study to investigate the safety tolerability pharmacokinetics PK and efficacy of RE-3964 doses of either 250 mg or 500 mg PO every 12 hours for the reduction of Clostridioides Difficile infection CDI
Detailed Description:
Approximately 80 individuals will be enrolled in this open-label Phase 2 study randomized 12 1 to receive oral doses of REC-3964 250 mg 500 mg or observation The purpose of this study is to investigate the safety tolerability pharmacokinetics PK and efficacy of REC-3964 for the reduction of recurrent Clostridioides difficile infection rCDI after initial cure with vancomycin Participants will receive treatment with REC-3964 for 28 days
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