Impact of rifampicin in treatment outcome of Cutibacterium acnes prosthetic joint infections - RIFACute

Phase 1

Recruiting

• Conditions: C. acnes prosthetic joint infection; MedDRA version: 21.1Level: PTClassification code: 10076118Term: Medical device site joint infection Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2022-502974-18-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 235

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, •Detection of C. acnes on two distinct per-operative samples collected during the single-stage or the two-stage revision;. At least one isolation by conventional culture method is required. 16s rDNA sequencing and metagenomic sequencing techniques can be used to define one sample or more as positive for C. acnes., •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

Exclusion Criteria

•Contraindication to Rifampicin (included ongoing treatment contraindicated with rifampicin), •Disease-modifying treatment incompatible with the inducer effect of rifampicin, •Liver cirrhosis, •Pregnancy: a pregnancy urinary 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 (MDRD), Contraindication to Amoxicillin AND moxifloxacin (included ongoing treatment contraindicated with these medicines)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified