Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 4:42 AM
Study NCT ID:
NCT03263832
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection
Sponsor:
BioFilm Control
Organization:
Study Overview
Official Title:
Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
BJIBiofilm
Brief Summary:
This is an observational study that does not change routine care.
The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.
The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.
Detailed Description:
The secondary objectives are:
A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management.
B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics.
C. Create an S. aureus strain collection for future ancillary studies
A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management.
B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics.
C. Create an S. aureus strain collection for future ancillary studies
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?:
None
Is an FDA AA801 Violation?: