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 groupsLocations
13LUMC2333ZA, LeidenZuid Hollans, Netherlands
Amsterdam UMC Amsterdam Netherlands
OLVG Amsterdam Netherlands
Martini ziekenhuis Groningen Netherlands
Sponsors 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