amoxicillin or moxifloxacin
DrugAntibiotic treatment back bone during 12 weeks
NCT Number: NCT05902221
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
CH Annecy Genevois, Annecy, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Antibiotic treatment back bone during 12 weeks
Antibiotic treatment back bone during 12 weeks + rifampicin
Time frame: 24 months after the end of antibiotic treatment
Defined by Relapse, New infection, early failure
Time frame: during rifampicin treatment
adverse events will be described by frequency and grade, throughout the treatment (classified according to the CTCAE 5.0.)
Time frame: 24 months after the end of antibiotic treatment
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
Defined by Relapse, New infection, early failure
Time frame: 12 months after the end of antibiotic treatment
Defined by Relapse, New infection, early failure
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
Acronym: RIFACute
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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