Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection

• Status: Recruiting
• Trial end date: 2028-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Alrijne Hospital; Elisabeth-TweeSteden Ziekenhuis; Erasmus Medical Center; Isala; Martini Hospital Groningen; Medical Centre Leeuwarden; Onze Lieve Vrouwe Gasthuis; Radboud University Medical Center; Reinier Haga Orthopedisch Centrum; Rijnstate Hospital; Sint Maartenskliniek; Spaarne Gasthuis; Tergooi Hospital; University Medical Center Groningen
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Levofloxacin; Rifampin

Criteria

Inclusion Criteria:

• >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 Criteria:

(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