NCT06172010 Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
| NCT ID | NCT06172010 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Leiden University Medical Center |
| Condition | Prosthetic-joint Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 316 participants in total. It began in 2023-04-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Henk Scheper, MD
STUDY DIRECTOR
LUMC
Frequently Asked Questions
Who can join the NCT06172010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prosthetic-joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06172010 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06172010 currently recruiting?
Yes, NCT06172010 is actively recruiting participants. Contact the research team at h.scheper@lumc.nl for enrollment information.
Where is the NCT06172010 trial being conducted?
This trial is being conducted at Leiden, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands, Groningen, Netherlands and 9 additional locations.
Who is sponsoring the NCT06172010 clinical trial?
NCT06172010 is sponsored by Leiden University Medical Center. The principal investigator is Henk Scheper, MD at LUMC. The trial plans to enroll 316 participants.