Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
RiCOTTA
1 other identifier
interventional
316
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2023
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 23, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
December 15, 2023
December 1, 2023
3.9 years
November 23, 2023
December 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
treatment success
Proportion of patients with treatment success 15 months after DAIR (=1 year after finishing antibiotic) in both randomised groups treatment). Treatment success will be defined as absence of all of the following: (I) Infection related re-surgery of the initially affected prosthetic joint (II) New antibiotic treatment for suspected or proven infection of the index joint. (III) Ongoing use of antibiotics for the index joint at the end of follow-up. (IV) Death
15 months after DAIR
Secondary Outcomes (3)
Quality of life of patients at baseline and after 6 and 12 weeks
at the time of randomization, at week 6 after surgical debridement and after 3 months.
Adverse events
through study completion, an average of 15 months
Development of new rifampicin resistance
through study completion, an average of 15 months
Study Arms (2)
Oral rifampicin-based combination therapy
ACTIVE COMPARATORrifampicin 450mg BID + levofloxacin 500mg BID in the oral treatment phase with a total duration of antibiotics of 12 weeks
Oral monotherapy with clindamycin
EXPERIMENTALclindamycin 600mg TID in the oral treatment phase with a total duration of antibiotics of 12 weeks
Interventions
antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
Eligibility Criteria
You may qualify if:
- \>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
You may not qualify if:
- (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 the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- University Medical Center Groningencollaborator
- Onze Lieve Vrouwe Gasthuiscollaborator
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)collaborator
- Frisius Medisch Centrumcollaborator
- Isalacollaborator
- Martini Hospital Groningencollaborator
- Radboud University Medical Centercollaborator
- Sint Maartenskliniekcollaborator
- Elisabeth-TweeSteden Ziekenhuiscollaborator
- Erasmus Medical Centercollaborator
- Alrijne Hospitalcollaborator
- Spaarne Gasthuiscollaborator
- Reinier Haga Orthopedisch Centrumcollaborator
- Tergooi Hospitalcollaborator
- Rijnstate Hospitalcollaborator
Study Sites (13)
LUMC
Leiden, Zuid Hollans, 2333ZA, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Martini ziekenhuis
Groningen, Netherlands
UMCG
Groningen, Netherlands
Spaarne gasthuis
Hoofddorp, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Alrijne Ziekenhuis
Leiderdorp, Netherlands
Radboud UMC
Nijmegen, Netherlands
Sint maartenskliniek
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Elisabeth Tweesteden Ziekenhus
Tilburg, Netherlands
Stichting Isala Klinieken
Zwolle, Netherlands
Related Publications (1)
Scheper H, Gerritsen LM, Pijls BG, Van Asten SA, Visser LG, De Boer MGJ. Outcome of Debridement, Antibiotics, and Implant Retention for Staphylococcal Hip and Knee Prosthetic Joint Infections, Focused on Rifampicin Use: A Systematic Review and Meta-Analysis. Open Forum Infect Dis. 2021 Jul 1;8(7):ofab298. doi: 10.1093/ofid/ofab298. eCollection 2021 Jul.
PMID: 34258321RESULT
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henk Scheper, MD
LUMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof dr MGJ de Boer
Study Record Dates
First Submitted
November 23, 2023
First Posted
December 15, 2023
Study Start
April 1, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
December 15, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share