A Phase 3 interventional study of amoxicillin or moxifloxacin and amoxicillin or moxifloxacin + rifampicin in Infections Joint Prosthetic, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 3, Interventional, and Treatment
Cutibacterium acnes is involved in nearly 40% of shoulder prosthetic joint infections (PJI). After shoulder prothesis, C. acnes mainly affects hip prosthesis. One recent work from the Lyon (France) bone and joint infections reference center with data focusing mainly on hip and knee PJI has reported that C. acnes is the leading cause of late-onset PJI after coagulase negative staphylococci (CNS) (late acute PJI not considered).
In such late-onset device-related infection, biofilm, as produced by C. acnes during PJI represents a major hurdle on the path to patient's cure. Because biofilm-associated bacteria have a slower metabolism and a lower multiplication rate than planktonic bacteria, antibiotic susceptibility can be hampered.
Rifampicin is an antibiotic with low minimal bactericidal concentration against S. aureus and CNS biofilm-associated bacteria8 which significantly influence patient's outcome during staphylococci PJI.
Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Amoxicillin or moxifloxacin to the investigator's discretion
Drug: amoxicillin or moxifloxacin
Amoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN
Drug: amoxicillin or moxifloxacin + rifampicin
Antibiotic treatment back bone during 12 weeks
Antibiotic treatment back bone during 12 weeks + rifampicin
Rate of C. acnes prosthetic joint infections management failure
Defined by Relapse, New infection, early failure
Time frame: 24 months after the end of antibiotic treatment
Rate of adverse event linked to rifampicin
adverse events will be described by frequency and grade, throughout the treatment (classified according to the CTCAE 5.0.)
Time frame: during rifampicin treatment
Rate of C. acnes prosthetic joint infections probable failure
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
Time frame: 24 months after the end of antibiotic treatment
Rate of C. acnes prosthetic joint infections management failure
Defined by Relapse, New infection, early failure
Time frame: 24 months after the end of antibiotic treatment
Rate of C. acnes prosthetic joint infections management failure
Defined by Relapse, New infection, early failure
Time frame: 12 months after the end of antibiotic treatment
Plan to share: No — Not planned
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Centre Hospitalier Universitaire de Nice