Antibiotic Resistant Infection Clinical Trial
Official title:
Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in
NCT number | NCT03848091 |
Other study ID # | 18-030 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2016 |
Est. completion date | January 1, 2018 |
Verified date | February 2024 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
One-step exchange arthroplasty is more and more used in the treatment of chronic infections, especially in patients at risk anesthetic. This strategy is not recommended in patients infected with multidrug-resistant organisms or difficult to treat because of a risk of bacterial persistence on the new implant. Antibiotic pretreatment by a narrow-spectrum molecule and for which resistance acquisition is difficult might be of interest to try to reduce the inoculum and avoid contamination of the new implant.
Status | Completed |
Enrollment | 13 |
Est. completion date | January 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - patients having had a antibiotic pretreatment targeted before a one step exchange arthroplasty Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
France | Hospices Civils de Lyon | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | |
Secondary | rate of use of this strategy | descriptions of patients managed with this strategy | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | |
Secondary | rate of bacteria responsible for infection | bacterial epidemiology | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption |
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