Trials / Not Yet Recruiting
Not Yet RecruitingNCT05902221
Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 235 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Nice · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | amoxicillin or moxifloxacin | Antibiotic treatment back bone during 12 weeks |
| DRUG | amoxicillin or moxifloxacin + rifampicin | Antibiotic treatment back bone during 12 weeks + rifampicin |
Timeline
- Start date
- 2024-03-30
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
- First posted
- 2023-06-13
- Last updated
- 2024-03-13
Locations
12 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05902221. Inclusion in this directory is not an endorsement.