prosthetic joint infection
Conditions
Brief summary
treatment success 15 months after DAIR (=1 year after finishing antibiotic treatment). Treatment success will be defined as absence of all of the following: (I) Infection related re-surgery of the initially affected prosthetic joint (II) New antibiotic treatment for suspected or proven infection of the index joint. (III) Ongoing use of antibiotics for the index joint at the end of follow-up. (IV) Death
Detailed description
Quality of life, measured with EQ-5D-5L questionnaires. This ‘quality of life’ questionnaire will be scored at the time of randomization, at week 6 after surgical debridement and after 3 months., The number of (S)AEs during antimicrobial treatment and follow up (including mortality)., The number of switches to a different oral regimen, The number of antibiotic side effects (classified by the modified Hartwig and Siegel scale)., The number of patients developing Clostridioides difficile infection during treatment., The occurrence of rifampicin resistance in bacteria in patients with a microbiologically confirmed failure of treatment, The difference in absolute risks of treatment succes with death unrelated to PJI as a competing event in a per-protocol analysis, The difference in absolute risks of treatment success in an intention to treat analysis
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment success 15 months after DAIR (=1 year after finishing antibiotic treatment). Treatment success will be defined as absence of all of the following: (I) Infection related re-surgery of the initially affected prosthetic joint (II) New antibiotic treatment for suspected or proven infection of the index joint. (III) Ongoing use of antibiotics for the index joint at the end of follow-up. (IV) Death | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, measured with EQ-5D-5L questionnaires. This ‘quality of life’ questionnaire will be scored at the time of randomization, at week 6 after surgical debridement and after 3 months., The number of (S)AEs during antimicrobial treatment and follow up (including mortality)., The number of switches to a different oral regimen, The number of antibiotic side effects (classified by the modified Hartwig and Siegel scale)., The number of patients developing Clostridioides difficile infection during treatment., The occurrence of rifampicin resistance in bacteria in patients with a microbiologically confirmed failure of treatment, The difference in absolute risks of treatment succes with death unrelated to PJI as a competing event in a per-protocol analysis, The difference in absolute risks of treatment success in an intention to treat analysis | — |
Countries
Netherlands