Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections
NCT ID: NCT05902221
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
235 participants
INTERVENTIONAL
2024-03-30
2027-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Utility of Levofloxacin-Rifampin in the Therapy of Prosthetic Joint Infection
NCT00279864
Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
NCT06172010
Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin
NCT03750721
Cohort of Prosthetic Joint Infections
NCT02801253
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
NCT05640336
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Antibiotic treatment backbone alone
Amoxicillin or moxifloxacin to the investigator's discretion
amoxicillin or moxifloxacin
Antibiotic treatment back bone during 12 weeks
Antibiotic treatment backbone + rifampicin
Amoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN
amoxicillin or moxifloxacin + rifampicin
Antibiotic treatment back bone during 12 weeks + rifampicin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
amoxicillin or moxifloxacin
Antibiotic treatment back bone during 12 weeks
amoxicillin or moxifloxacin + rifampicin
Antibiotic treatment back bone during 12 weeks + rifampicin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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);
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CH Annecy Genevois
Annecy, , France
CHU de BORDEAUX
Bordeaux, , France
HCL
Lyon, , France
AP-HM
Marseille, , France
CHU de MONTPELLIER
Montpellier, , France
CHU de Nantes
Nantes, , France
CHU de NICE
Nice, , France
Dianonesses croix saint simon
Paris, , France
CHU de Rennes
Rennes, , France
CHU Toulouse
Toulouse, , France
Ch Tourcoing
Tourcoing, , France
CHRU Tours
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-APN-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.