NCT03796104

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

January 4, 2019

Last Update Submit

April 12, 2023

Conditions

Keywords

Bone and Joint InfectionStaphylococcus Aureuschronic infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of Treatment Failure

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Study Arms (2)

Deficiency of delta-hemolysine

Implant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency

Other: Delta-haemolysin

Presence of delta-hemolysine

Implant infected by Staphylococcus aureus with delta-haemolysin Production

Other: Delta-haemolysin

Interventions

comparison of groups having infection with S. aureus with and without delta-haemolysin Production

Deficiency of delta-hemolysinePresence of delta-hemolysine

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having implant infection due to S. aureus treated by DAIR managed at the Lyon Bone and joint infection reference Center between 2006 and 2018

You may qualify if:

  • patients having implant infection due to S. aureus treated by DAIR

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Staphylococcal InfectionsPersistent Infection

Interventions

delta hemolysin protein, Staphylococcus aureus

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • FLORENT VALOUR, Md,PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Boulant, CRA

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical research assistant

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 8, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations