Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
Recruiting now · Phase 4
Conditions studied: Prosthetic-joint Infection, Infection Hip, Infection; Knee, Joint
In brief
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.
Key facts
- Study ID
- NCT06172010
- Run by
- Leiden University Medical Center
- People needed
- 316
- Starts
- 2023-04-01
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2023-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- >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
You may not qualify if…
- (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
Where it is running
- Stichting Isala Klinieken — Zwolle, Netherlands (enrolling)
- Amsterdam UMC — Amsterdam, Netherlands (enrolling)
- OLVG — Amsterdam, Netherlands (enrolling)
- Elisabeth Tweesteden Ziekenhus — Tilburg, Netherlands (enrolling)
- LUMC — Leiden, Zuid Hollans, Netherlands (enrolling)
- UMCG — Groningen, Netherlands (enrolling)
- Spaarne gasthuis — Hoofddorp, Netherlands (enrolling)
- Medisch Centrum Leeuwarden — Leeuwarden, Netherlands (enrolling)
- Alrijne Ziekenhuis — Leiderdorp, Netherlands (enrolling)
- Radboud UMC — Nijmegen, Netherlands (enrolling)
- Sint maartenskliniek — Nijmegen, Netherlands (enrolling)
- Martini ziekenhuis — Groningen, Netherlands
- Erasmus MC — Rotterdam, Netherlands
Full record on ClinicalTrials.gov
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