Infections Joint ProstheticPhase 3RIFACuteNCT05902221
Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections
A Phase 3 study testing amoxicillin or moxifloxacin and amoxicillin or moxifloxacin + rifampicin in people with Infections Joint Prosthetic, run by Centre Hospitalier Universitaire de Nice at 13 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections Joint Prosthetic
- What is being tested?
- amoxicillin or moxifloxacin and amoxicillin or moxifloxacin + rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 13 sitesFrance
- Study dates
- 2 May 2024to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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);
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
CH Annecy Genevois
Annecy
Gabriel MACHEDA, gmacheda@ch-annecygenevois.fr
- Recruiting
CHU de BORDEAUX
Bordeaux
Fredéric DAUCHY, frederic.dauchy@chu-bordeaux.fr
- Recruiting
Hôpital Ambroise Paré
Boulogne
Aurélien DINH, +33147107760, aurelien.dinh@aphp.fr
- Recruiting
HCL
Lyon
Tristan FERRY, tristan.ferry@chu-lyon.fr
Florent VALOUR, florent.valour@chu-lyon.fr
- Not yet recruiting
AP-HM
Marseille
Carole ELDIN, carole.eldin@ap-hm.fr
- Recruiting
CHU de MONTPELLIER
Montpellier
Vincent LE MOIGN, v-le_moing@chu-montpellier.fr
- Recruiting
CHU de Nantes
Nantes
Raphaël LECOMTE, raphael.lecomte@chu-nantes.fr
- Recruiting
CHU de NICE
Nice, 06200
Johan COURJON, +33492034562, courjon.j@chu-nice.fr
Irit TOUITOU, +3349203847, touitou.i@chu-nice.fr
- Recruiting
Dianonesses croix saint simon
Paris
Valérie ZELLER, vzeller@hopital-dcss.org
- Recruiting
CHU de Rennes
Rennes
Cédric ARVIEUX, cedric.arvieux@chu-rennes.fr
- Recruiting
CHU Toulouse
Toulouse
Philippe DELOBEL, delobel.p@chu-toulouse.fr
- Recruiting
Ch Tourcoing
Tourcoing
Benoît GACHET, bgachet@ch-tourcoing.fr
- Recruiting
CHRU Tours
Tours
Marion LACASSE, M.LACASSE@chu-tours.fr
About this study
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.
- Conditions
- Infections Joint Prosthetic
- Being tested
- amoxicillin or moxifloxacin, amoxicillin or moxifloxacin + rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin or moxifloxacinDrug
Antibiotic treatment back bone during 12 weeks
amoxicillin or moxifloxacin + rifampicinDrug
Antibiotic treatment back bone during 12 weeks + rifampicin
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment backbone alone | Active comparator | Amoxicillin or moxifloxacin to the investigator's discretion Receives: Drug: amoxicillin or moxifloxacin |
| Antibiotic treatment backbone + rifampicin | Experimental | Amoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN Receives: Drug: amoxicillin or moxifloxacin + rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of C. acnes prosthetic joint infections management failure
Defined by Relapse, New infection, early failure
Measured: 24 months after the end of antibiotic treatment
Rate of adverse event linked to rifampicin
adverse events will be described by frequency and grade, throughout the treatment (classified according to the CTCAE 5.0.)
Measured: during rifampicin treatment
Secondary outcomes (3)
Rate of C. acnes prosthetic joint infections probable failure
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
Measured: 24 months after the end of antibiotic treatment
Rate of C. acnes prosthetic joint infections management failure
Defined by Relapse, New infection, early failure
Measured: 24 months after the end of antibiotic treatment
Rate of C. acnes prosthetic joint infections management failure
Defined by Relapse, New infection, early failure
Measured: 12 months after the end of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start2 May 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections Joint ProstheticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized two-arm (parallel) comparative open-label cohort clinical trial.
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902221
- Sponsor's protocol ID
- 21-APN-02
- Acronym
- RIFACute
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections
- ClinicalTrials.gov ID
- NCT05902221
- Acronym / sponsor ID
- RIFACute / 21-APN-02
- Conditions
- Infections Joint Prosthetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized two-arm (parallel) comparative open-label cohort clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment backbone alone | Active comparator | Drug: amoxicillin or moxifloxacinAmoxicillin or moxifloxacin to the investigator's discretion |
| Antibiotic treatment backbone + rifampicin | Experimental | Drug: amoxicillin or moxifloxacin + rifampicinAmoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillin or moxifloxacinAntibiotic treatment back bone during 12 weeks | Drug | Antibiotic treatment backbone alone |
| amoxicillin or moxifloxacin + rifampicinAntibiotic treatment back bone during 12 weeks + rifampicin | Drug | Antibiotic treatment backbone + rifampicin |
Primary outcome
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
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.)
3 secondary outcomes
Rate of C. acnes prosthetic joint infections probable failure
Time frame: 24 months after the end of antibiotic treatment
Rate of C. acnes prosthetic joint infections management failure
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Not planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amoxicillin or moxifloxacin and amoxicillin or moxifloxacin + rifampicin in people with Infections Joint Prosthetic, run by Centre Hospitalier Universitaire de Nice at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan COURJON, MD (+33(0)492034562, courjon.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of C. acnes prosthetic joint infections management failure (time frame: 24 months after the end of antibiotic treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.