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NCT03796104 Clinical Trial

Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR

Staphylococcus Aureus Clinical Trial

Official title:
Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03796104
Other study ID # 18-333
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2023

Study information
Verified date April 2023
Source Hospices Civils de Lyon
Contact Johanna Boulant, CRA
Email johanna.boulant@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - patients having implant infection due to S. aureus treated by DAIR Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Delta-haemolysin
comparison of groups having infection with S. aureus with and without delta-haemolysin Production

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary Rate of Treatment Failure 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 Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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