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Impact of rifampicin in treatment outcome of Cutibacterium spp. prosthetic joint infections - RIFACute
EU CTIS ID: 2022-502974-18-00
What this study is testing
Two main objectives will be analyzed according to the hierarchical sequential procedure (closed-testing procedure) in the following order: 1.To study the safety of rifampicin during C. spp. prosthetic joint infection treatment 2.To study the efficacy of rifampicin during C. spp. prosthetic joint infection treatment
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age: > or = 18 years old
- • Monomicrobial, rifampicin susceptible Cutibacterium spp. 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 (complete or single-pole replacement are authorised); for late infections (more than 4 weeks after surgery) or with DAIR (less than 4 weeks after surgery)
- • Detection of C. spp. 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. spp. and the medical history of the patient, the PJI can be treated with amoxicillin or moxifloxacin
You likely can't join if
- • 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)
See the full eligibility criteria
- • Age: > or = 18 years old
- • Monomicrobial, rifampicin susceptible Cutibacterium spp. 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 (complete or single-pole replacement are authorised); for late infections (more than 4 weeks after surgery) or with DAIR (less than 4 weeks after surgery)
- • Detection of C. spp. 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. spp. and the medical history of the patient, the PJI can be treated with amoxicillin or moxifloxacin
- • 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)
- Rifampicin prior to randomization for current episode of arthroplasty infection;
- Management not planned with a curative aim, suppressive antibiotic treatment is considered.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.