Status:
RECRUITING
Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
University Medical Center Groningen
Onze Lieve Vrouwe Gasthuis
Conditions:
Prosthetic-joint Infection
Infection Hip
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 rif...
Detailed Description
This is a pragmatic, multicenter, randomized controlled open label trial with a non-inferiority design, comparing the efficacy of rifampicin-based combination antimicrobial therapy versus antimicrobia...
Eligibility Criteria
Inclusion
- \>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
- (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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT06172010
Start Date
April 1 2023
End Date
March 1 2028
Last Update
December 15 2023
Active Locations (13)
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1
LUMC
Leiden, Zuid Hollans, Netherlands, 2333ZA
2
Amsterdam UMC
Amsterdam, Netherlands
3
OLVG
Amsterdam, Netherlands
4
Martini ziekenhuis
Groningen, Netherlands