Comparing two antibiotic treatments for joint infections caused by Staphylococcus
Rifampicin Combination Therapy Versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection
This study tests whether a combination of two antibiotics can work better than just one to treat joint infections caused by Staphylococcus in adults with hip or knee infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 316 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (Leiden, Zuid Hollans and 12 other locations) |
| Trial ID | NCT06172010 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed staphylococcal prosthetic hip or knee joint infections treated by the DAIR strategy.
Not a fit: Patients with contraindications to rifampicin, levofloxacin, or clindamycin, or those requiring long-term intravenous antibiotic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from staphylococcal prosthetic joint infections.
How similar studies have performed: Previous studies have shown promise in using combination antibiotic therapies for similar infections, but this specific approach is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden, Zuid Hollans and 12 other locations
- Lumc — Leiden, Zuid Hollans, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Recruiting)
- Martini ziekenhuis — Groningen, Netherlands (Not_yet_recruiting)
- Umcg — Groningen, Netherlands (Recruiting)
- Spaarne gasthuis — Hoofddorp, Netherlands (Recruiting)
- Medisch Centrum Leeuwarden — Leeuwarden, Netherlands (Recruiting)
- Alrijne Ziekenhuis — Leiderdorp, Netherlands (Recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
- Sint maartenskliniek — Nijmegen, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, Netherlands (Not_yet_recruiting)
- Elisabeth Tweesteden Ziekenhus — Tilburg, Netherlands (Recruiting)
- Stichting Isala Klinieken — Zwolle, Netherlands (Recruiting)
Study contacts
- Study coordinator: Henk Scheper, MD
- Email: h.scheper@lumc.nl
- Phone: 071-5299239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.