Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections (RIFACute)

March 12, 2024 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

235

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antibiotic treatment backbone alone
Amoxicillin or moxifloxacin to the investigator's discretion
Drug: amoxicillin or moxifloxacin
Antibiotic treatment back bone during 12 weeks
Experimental: Antibiotic treatment backbone + rifampicin
Amoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN
Drug: amoxicillin or moxifloxacin + rifampicin
Antibiotic treatment back bone during 12 weeks + rifampicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months after the end of antibiotic treatment
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.)
during rifampicin treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months after the end of antibiotic treatment
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
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
Defined by Relapse, New infection, early failure
12 months after the end of antibiotic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-APN-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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