infection at the site of the prosthesis Periprosthetic joint infections
Conditions
Interventions
Antibiotics, observational
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years. - Written informed consent has been obtained from the patient or their legally authorized representative. - Suffering from periprosthetic (hip or knee) joint infections and therefore treated with one of the following antibiotics as part of the one-stage wo-stage arthroplasty exchange: IV: vancomycin, flucloxacillin or cefuroxime Oral: flucloxacillin, clindamycin or co-trimoxazole or ciprofloxacine - Patients undergoing a two-stage implant exchange of hip or knee with or without antibiotic free interval prior to re-implantation. - Able and willing to undergo joint punctures and venous blood sampling during and, in case of an antibiotic free interval, at the end of the six-weeks antibiotic treatment.
Exclusion criteria
Exclusion criteria: - Unable to draw samples for study purposes; Except when a patient received a vancomycin-loaded spacer, then they will remain included. - Language barriers. - The use of the target antibiotics at the start of study participation (and therefore at the start of the antibiotic treatment as part of the two-stage arthroplasty exchange). - The use of drugs interacting with the target antibiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK/PD indices are calculated. The treatment drug Minimal Inhibitory Concentration (MIC) for the isolated pathogen and the free (unbound) drug exposure value are used to calculate pharmacodynamic indices. Epidemiological cut-off value (ECOFF) and MIC data for the expected bacteria will be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| - PK/PD model to evaluate the relation between antibiotic dosage, blood- and infection site concentration (estimating covariates) for the different antibiotics of interest and knee versus hip. - Differences in target site concentration of the antibiotics between THA and TKA patients suffering from PJI. - The number and type of drug-related adverse events occurring during the antimicrobial treatment. - Differences in target site concentration and antibiotic exposure (measured in concentration with respect to the MIC of the bacteria) between patients treated with the antibiotic therapy applied during the two-stage arthroplasty exchange and patients treated with the former in combination with an antibiotic-loaded spacer. - Duration of antibiotic elution from antibiotic-loaded spacers. | — |
Countries
Netherlands
Contacts
Public ContactBCP Koch
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed