NCT03750721

Brief Summary

S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1 month

First QC Date

August 7, 2018

Last Update Submit

November 20, 2018

Conditions

Bone and Joint InfectionAntibiotic Resistant Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (1)

  • description of the use of rifampicin : rate of use

    the aim is to determine how the use of rifampin influence the prognosis in staphylococcal acute post-operative prosthetic joint infection treated with DAIR

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

Secondary Outcomes (2)

  • rate of failure for treatment using rifampin

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

  • rate of adverse event with rifampin

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

Study Arms (1)

Role of rifampin in staphylococcal PJI

retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (\< 1 month) PJI treated with DAIR in 2011-2016 period

Other: Role of rifampin in staphylococcal PJI

Interventions

Role of rifampin in staphylococcal PJIOTHER

the aim is to determine if the dose and the duration of rifampin influenced the prognosis

Role of rifampin in staphylococcal PJI

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (\< 1 month) PJI treated with DAIR in 2011-2016 period

You may qualify if:

  • patients having had acute PJI (i.e. \<1 month following the implantation), DAIR with exchange of removal components) due to S. aureus and coagulase-negative staphylococci (2011-2016)

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

Location

Study Officials

  • Tristan FERRY, Md,PhD

    Hospices Civils de Lyon Hôpital de la Croix-Rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Assistant

Study Record Dates

First Submitted

August 7, 2018

First Posted

November 23, 2018

Study Start

April 1, 2018

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

FR(1)