C. spp. prosthetic joint infection
Conditions
Brief summary
1. Rate of C. spp. prosthetic joint infections management failure defined by: RELAPSE or NEW INFECTION or EARLY FAILURE, 2. Rate of adverse event linked to rifampicin, classified according to the CTCAE 5.0. The adverse events will be described by frequency and grade, throughout the treatment, with the maximum grade over all cycles used as the summary measure for each patient.
Detailed description
1. Rate of C. spp. prosthetic joint infections probable failure suspected in case of specific clinical signs (fistula) and/or inflammatory synovial fluid without microbiological positive results and/or histopathological results after revision without microbiological positive results during the 24 months of follow-up, 2. Rate of C. spp. prosthetic joint infections management failure (as defined for the primary endpoint) during the 24 months of follow-up according to the two usable companions in the trial (amoxicillin and moxifloxacin)., Rate of C. spp. prosthetic joint infections management failure (as defined for the primary end-point) during the 12 months of follow-up
Interventions
DRUGCLINDAMYCIN
DRUGMOXIFLOXACIN
DRUGRIMACTAN 300 mg
DRUGgélule
DRUGRifadine 300 mg gélules
DRUGAMOXICILLIN
DRUGDOXYCYCLINE
Sponsors
Centre Hospitalier Universitaire De Nice
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of C. spp. prosthetic joint infections management failure defined by: RELAPSE or NEW INFECTION or EARLY FAILURE, 2. Rate of adverse event linked to rifampicin, classified according to the CTCAE 5.0. The adverse events will be described by frequency and grade, throughout the treatment, with the maximum grade over all cycles used as the summary measure for each patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of C. spp. prosthetic joint infections probable failure suspected in case of specific clinical signs (fistula) and/or inflammatory synovial fluid without microbiological positive results and/or histopathological results after revision without microbiological positive results during the 24 months of follow-up, 2. Rate of C. spp. prosthetic joint infections management failure (as defined for the primary endpoint) during the 24 months of follow-up according to the two usable companions in the trial (amoxicillin and moxifloxacin)., Rate of C. spp. prosthetic joint infections management failure (as defined for the primary end-point) during the 12 months of follow-up | — |
Countries
France
Outcome results
None listed