Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infe
In this Dutch multicenter clinical trial, patients with a staphylococcal prosthetic joint infection, will, in the oral antibiotic treatment phase, be randomized between clindamycin monotherapy and rifampicin / levofloxacin combination therapy. The clinical endpoint will be treatment success one year after finishing ant
| Condition(s) | Prosthetic-joint Infection, Infection Hip, Infection; Knee, Joint |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | In this Dutch multicenter clinical trial, patients with a staphylococcal prosthetic joint infection, will, in the oral antibiotic treatment phase, be randomized between clindamycin monotherapy and rifampicin / levofloxacin combination therapy. The clinical endpoint will be treatment success one year after finishing antimicrobial treatment. |
| Who can participate | Inclusion Criteria: * \>18 years of age * Confirmed staphylococcal prosthetic hip or knee joint infection according to the current EBJIS 2021 definition of PJI * The causative agents are (or include) S. aureus or and/or Coagulase-negative staphylococci (CNS) * Treatment is according to the DAIR-procedure Exclusion Criteria: (i) a contra-indication for rifampicin (e.g. a resistant strain or proven allergic reaction or difficult drug-drug-interactions) (ii) complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment \> 2 weeks (iii) An infection for which there are no suitable antibiotic choices to permit Randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics) (iv) treatment fail |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Leiden University Medical Center |
| Locations | Leiden, Zuid Hollans, Netherlands; Amsterdam, Netherlands; Amsterdam, Netherlands; Groningen, Netherlands; Groningen, Netherlands; Hoofddorp, Netherlands (+7 more sites) |
| Start date | 2023-04-01 |
| NCT ID | NCT06172010 |
| Official listing | https://clinicaltrials.gov/study/NCT06172010 |