Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
>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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Clindamycin
- Rifampicin and levofloxacin
Treatment groups
316 Participants
are divided into 2 treatment groupsSponsors and collaborators
Leiden University Medical Center
Lead sponsor
University Medical Center Groningen
Collaborator
Onze Lieve Vrouwe Gasthuis
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Frisius Medisch Centrum
Collaborator
Isala
Collaborator
Martini Hospital Groningen
Collaborator
Radboud University Medical Center
Collaborator
Sint Maartenskliniek
Collaborator
Elisabeth-TweeSteden Ziekenhuis
Collaborator
Erasmus Medical Center
Collaborator
Alrijne Hospital
Collaborator
Spaarne Gasthuis
Collaborator
Reinier Haga Orthopedisch Centrum
Collaborator
Tergooi Hospital
Collaborator
Rijnstate Hospital
Collaborator
Source ClinicalTrials.gov