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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03750721
Other study ID # 18-040
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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:

Study Design


Related Conditions & MeSH terms


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)
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