drugset / Trial / NCT06172010
Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
Phase 4
Recruiting
316 enrolled
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabAlrijne Hospital · collabElisabeth-TweeSteden Ziekenhuis · collabErasmus Medical Center · collabFrisius Medisch Centrum · collabIsala · collabMartini Hospital Groningen · collabOnze Lieve Vrouwe Gasthuis · collabRadboud University Medical Center · collabReinier Haga Orthopedisch Centrum · collabRijnstate Hospital · collabSint Maartenskliniek · collabSpaarne Gasthuis · collabTergooi Hospital · collabUniversity Medical Center Groningen · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-04-01
- Primary completion
- 2027-03
- Completion
- 2028-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clindamycin | Unknown | 600 mg | Oral |
| Comparator | Levofloxacin | Small molecule | 500 mg | Oral |
| Comparator | Rifampin | Small molecule | 450 mg | Oral |