RecruitingPhase 4NCT06172010

Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection

Rifampicin Combination Therapy Versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection


Sponsor

Leiden University Medical Center

Enrollment

316 participants

Start Date

Apr 1, 2023

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • >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 Criteria1

  • (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 failure before the start of oral therapy, (v) an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (vi) patients with an expected life expectancy <12 months, (vii) patients with a tumor prosthesis (viii) patients receiving chemotherapy for active malignancy in the next 12 months (ix) patients who are scheduled in advance for chronic suppressive antibiotic therapy for >12 months, (x) The patient is unlikely to comply with trial requirements following Randomization in the opinion of the investigator (xi) Pregnancy (xii) Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study

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Interventions

DRUGClindamycin

antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection

DRUGRifampicin and levofloxacin

antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection


Locations(13)

LUMC

Leiden, Zuid Hollans, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Martini ziekenhuis

Groningen, Netherlands

UMCG

Groningen, Netherlands

Spaarne gasthuis

Hoofddorp, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Alrijne Ziekenhuis

Leiderdorp, Netherlands

Radboud UMC

Nijmegen, Netherlands

Sint maartenskliniek

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Elisabeth Tweesteden Ziekenhus

Tilburg, Netherlands

Stichting Isala Klinieken

Zwolle, Netherlands

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NCT06172010