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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic treatment backbone alone | Active Comparator | Amoxicillin or moxifloxacin to the investigator's discretion |
|
| Antibiotic treatment backbone + rifampicin | Experimental | Amoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amoxicillin or moxifloxacin | Drug | Antibiotic treatment back bone during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of C. acnes prosthetic joint infections management failure | Defined by Relapse, New infection, early failure | 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.) | during rifampicin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months after the end of antibiotic treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan COURJON, MD | Contact | +33(0)492034562 | courjon.j@chu-nice.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy Genevois | Recruiting | Annecy | France |
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Multicenter, randomized two-arm (parallel) comparative open-label cohort clinical trial.
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| amoxicillin or moxifloxacin + rifampicin | Drug | Antibiotic treatment back bone during 12 weeks + rifampicin |
|
| Rate of C. acnes prosthetic joint infections management failure | Defined by Relapse, New infection, early failure | 24 months after the end of antibiotic treatment |
| Rate of C. acnes prosthetic joint infections management failure | Defined by Relapse, New infection, early failure | 12 months after the end of antibiotic treatment |
| CHU de BORDEAUX | Recruiting | Bordeaux | France |
|
| Hôpital Ambroise Paré | Recruiting | Boulogne | France |
|
| HCL | Recruiting | Lyon | France |
|
| AP-HM | Not yet recruiting | Marseille | France |
|
| CHU de MONTPELLIER | Recruiting | Montpellier | France |
|
| CHU de Nantes | Recruiting | Nantes | France |
|
| CHU de NICE | Recruiting | Nice | 06200 | France |
|
| Dianonesses croix saint simon | Recruiting | Paris | France |
|
| CHU de Rennes | Recruiting | Rennes | France |
|
| CHU Toulouse | Recruiting | Toulouse | France |
|
| Ch Tourcoing | Recruiting | Tourcoing | France |
|
| CHRU Tours | Recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D000077266 | Moxifloxacin |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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