Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250023
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2023-11-29
Brief Title:
SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis SAVE - a Open Label Non-inferiority Nation-wide Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SAVE
Brief Summary:
Background The current Danish National Guideline for treatment of pyogenic vertebral osteomyelitis PVO recommends 6 weeks antibiotic AB treatment with a 2-week intravenous IV AB lead-in followed by 4 weeks oral AB for uncomplicated PVO and 12 weeks AB treatment with a 2-4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO
The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline
The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None