Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin

Bone and Joint Infection Clinical Trial

— IPASTAPH  

Official title:

Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750721
• Other study ID #: 18-040
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: November 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

Related Conditions & MeSH terms

• Antibiotic Resistant Staphylococcus Aureus Infection
• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infection
• Staphylococcal Infections

Intervention

Other:
• Role of rifampin in staphylococcal PJI
the aim is to determine if the dose and the duration of rifampin influenced the prognosis

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	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	rate of failure for treatment using rifampin	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary	rate of adverse event with rifampin	Description of adverses events leading to stop the rifampicin	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)