Comparing two antibiotic treatments for joint infections caused by Staphylococcus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter clinical trial in the Netherlands aims to compare the effectiveness of rifampicin and levofloxacin combination therapy against clindamycin monotherapy in treating staphylococcal prosthetic joint infections. Patients aged 18 and older diagnosed with hip or knee infections will be randomized to receive either treatment during the oral antibiotic phase. The study will follow participants for 15 months to assess treatment success based on predefined clinical endpoints. The trial employs a pragmatic, randomized controlled design to evaluate the non-inferiority of the combination therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Lumc
  Leiden, Zuid Hollans, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Olvg
  Amsterdam, Netherlands Recruiting
• Umcg
  Groningen, Netherlands Recruiting
• Spaarne gasthuis
  Hoofddorp, Netherlands Recruiting
• Medisch Centrum Leeuwarden
  Leeuwarden, Netherlands Recruiting

Study contacts

• Study coordinator: Henk Scheper, MD
• Email: h.scheper@lumc.nl
• Phone: 071-5299239

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.