Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR
Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03796104
Collaborator
(none)
700
1
54.9
12.7
Study Details
Study Description
Brief Summary
The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
700 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR
Actual Study Start Date
:
Jan 1, 2018
Actual Primary Completion Date
:
Dec 31, 2018
Anticipated Study Completion Date
:
Jul 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Deficiency of delta-hemolysine Implant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency |
Other: Delta-haemolysin
comparison of groups having infection with S. aureus with and without delta-haemolysin Production
|
| Presence of delta-hemolysine Implant infected by Staphylococcus aureus with delta-haemolysin Production |
Other: Delta-haemolysin
comparison of groups having infection with S. aureus with and without delta-haemolysin Production
|
Outcome Measures
Primary Outcome Measures
- Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus [Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption]
patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups
Secondary Outcome Measures
- Rate of Treatment Failure [Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption]
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor. Comparison between the 2 groups
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
- patients having implant infection due to S. aureus treated by DAIR
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospices Civils de Lyon | Lyon | France | 69004 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: FLORENT VALOUR, Md,PhD, Hospices Civils de Lyon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eugénie MABRUT,
clinical research assistant,
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03796104
Other Study ID Numbers:
- 18-333
First Posted:
Jan 8, 2019
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eugénie MABRUT,
clinical research assistant,
Hospices Civils de Lyon
Additional relevant MeSH terms: