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NCT Number: NCT05902221

Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CH Annecy Genevois, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: > or =18 years old;
  • Monomicrobial, rifampicin susceptible Cutibacterium acnes late total knee arthroplasty (TKA) or hip arthroplasty (total, THA or hemiarthroplasty, HH) or shoulder arthroplasty (total, TSA or hemiarthroplasty, SH) infection treated surgically with single-stage or two-stage revision;
  • Isolation of C. acnes on two distinct per-operative samples collected during the single-stage or the two-stage revision
  • Based on the antimicrobial susceptibility test of the C. acnes and the medical history of the patient, the PJI can be treated with amoxicillin or moxifloxacin;
  • Women considered of childbearing potential (WOCBP) requires use of a highly effective contraceptive measure as intrauterine device (IUD), intrauterine hormone-releasing system (IUS), documented bilateral tubal occlusion, documented vasectomised partner, sexual abstinence. Contraception should be maintained during treatment and until the end of relevant systemic exposure.

Exclusion criteria

  • Contraindication to Rifampicin (included ongoing treatment contraindicated with rifampicin)
  • Contraindication to Amoxicillin AND moxifloxacin (included ongoing treatment contraindicated with these medicines)
  • Empirical antibiotic treatment not administered during the 24 hours following revision surgery;
  • Inactive empirical antibiotic treatment following surgery according to the AST of the bacteria;
  • disease-modifying treatment incompatible with the inducer effect of rifampicin
  • Liver cirrhosis;
  • Pregnancy: a pregnancy blood test will be performed on all women of childbearing age. The results will be sent to the patient by the doctor of their choice;
  • Porphyria;
  • Renal insufficiency with GFR < 30ml/min/1.73 m2 (CKD-EPI);

Treatment and study plan

amoxicillin or moxifloxacin

Drug

Antibiotic treatment back bone during 12 weeks

amoxicillin or moxifloxacin + rifampicin

Drug

Antibiotic treatment back bone during 12 weeks + rifampicin

Primary outcomes

  1. Rate of C. acnes prosthetic joint infections management failure

    Time frame: 24 months after the end of antibiotic treatment

    Defined by Relapse, New infection, early failure

  2. Rate of adverse event linked to rifampicin

    Time frame: during rifampicin treatment

    adverse events will be described by frequency and grade, throughout the treatment (classified according to the CTCAE 5.0.)

Secondary outcomes

  1. Rate of C. acnes prosthetic joint infections probable failure

    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

  2. Rate of C. acnes prosthetic joint infections management failure

    Time frame: 24 months after the end of antibiotic treatment

    Defined by Relapse, New infection, early failure

  3. Rate of C. acnes prosthetic joint infections management failure

    Time frame: 12 months after the end of antibiotic treatment

    Defined by Relapse, New infection, early failure

Study contacts

Contact information is provided by the study sponsor or research team.

Johan COURJON, MD

CONTACT

[email protected]

+33(0)492034562

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: RIFACute

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 13, 2023
Registry last updated
Jun 22, 2026

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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