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
This trial does not accept healthy volunteersQualifiers
>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
Design model
Parallel
Treatments tested in this trial
Clindamycin
Drugantimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
Rifampicin and levofloxacin
Drugantimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
Treatment groups
316 Participants
are divided into 2 treatment groupsGroup A: Oral rifampicin-based combination therapyActive comparator 1 intervention
Group B: Oral monotherapy with clindamycinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
treatment success
Proportion of patients with treatment success 15 months after DAIR (=1 year after finishing antibiotic) in both randomised groups treatment). Treatment success will be defined as absence of all of the following: (I) Infection related re-surgery of the initially affected prosthetic joint (II) New antibiotic treatment for suspected or proven infection of the index joint. (III) Ongoing use of antibiotics for the index joint at the end of follow-up. (IV) Death
Time frame
15 months after DAIRSecondary outcomes
1
Quality of life of patients at baseline and after 6 and 12 weeks
Quality of life, measured with the 5-level EQ-5D version (EQ-5D-5L) questionnaires. The number and percentage of patients reporting each level of problem on each dimension of the EQ-5D-5L will be decribed.
Time frame
at the time of randomization, at week 6 after surgical debridement and after 3 months.2
Adverse events
The number of (S)AEs during antimicrobial treatment and follow up (including mortality). ii. The proportion of patients switching to a different oral regimen in both study arms iii. The proportion of patient with antibiotic side effects (classified by the modified Hartwig and Siegel scale) in both study arms iv. The proportion of patient developing Clostridioides difficile infection during treatment in both study arms v. The proportion of patient with rifampicin resistance in bacteria in patients with a microbiologically confirmed failure of treatment in both study arms.
Time frame
through study completion, an average of 15 months3
Development of new rifampicin resistance
The proportion of patients developing rifampicin resistance in patients with a confirmed microbiological relapse with the same micro-organism in both study arms
Time frame
through study completion, an average of 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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