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Recruiting NCT05902221

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

Phase III Interventional Infections Joint Prosthetic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: amoxicillin or moxifloxacin, amoxicillin or moxifloxacin + rifampicin.
Who it may be relevant to
Registry conditions: Infections Joint Prosthetic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug amoxicillin or moxifloxacin
    Antibiotic treatment back bone during 12 weeks
  • Drug amoxicillin or moxifloxacin + rifampicin
    Antibiotic treatment back bone during 12 weeks + rifampicin

Primary outcome measures

  • Rate of C. acnes prosthetic joint infections management failure [Time frame: 24 months after the end of antibiotic treatment]
  • Rate of adverse event linked to rifampicin [Time frame: during rifampicin treatment]
Secondary outcome measures (3)
  • Rate of C. acnes prosthetic joint infections probable failure [Time frame: 24 months after the end of antibiotic treatment]
  • Rate of C. acnes prosthetic joint infections management failure [Time frame: 24 months after the end of antibiotic treatment]
  • Rate of C. acnes prosthetic joint infections management failure [Time frame: 12 months after the end of antibiotic treatment]

Eligibility criteria

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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 13 centers
  • CH Annecy Genevois — Annecy
  • CHU de BORDEAUX — Bordeaux
  • Hôpital Ambroise Paré — Boulogne
  • HCL — Lyon
  • AP-HM — Marseille
  • CHU de MONTPELLIER — Montpellier
  • CHU de Nantes — Nantes
  • CHU de NICE — Nice
  • … and 5 more centers

Identifiers

NCT: NCT05902221 · 21-APN-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗