BridgeMD
New treatment option for Infections Joint Prosthetic
Official title Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections
ClinicalTrials.gov ID: NCT05902221
What this study is testing
What is amoxicillin or moxifloxacin?
amoxicillin or moxifloxacin is an investigational medicine, being studied as a potential treatment for infections joint prosthetic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cutibacterium acnes is involved in nearly 40% of shoulder prosthetic joint infections (PJI). After shoulder prothesis, C.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: \> or =18 years old;
- Monomicrobial, rifampicin susceptible Cutibacterium acnes late total knee arthroplasty (TKA) or hip arthroplasty (total, THA or hemiarthroplasty, HH)...
- 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...
- Women considered of childbearing potential (WOCBP) requires use of a highly effective contraceptive measure as intrauterine device (IUD)...
You likely can't join if
- 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;
See the full eligibility 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)...
- 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...
- 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);
The study team makes the final eligibility decision.
Where it's taking place
- Annecy, France
- Bordeaux, France
- Boulogne, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Paris, France
- Rennes, France
- Toulouse, France
- Tourcoing, France
- Tours, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Annecy, France; Bordeaux, France; Boulogne, France; Lyon, France; Marseille, France; Montpellier, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.