Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
NCT ID: NCT06172010
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
316 participants
INTERVENTIONAL
2023-04-01
2028-03-31
Brief Summary
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Detailed Description
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All adult patients, aged 18 years or older, diagnosed and hospitalized with hip- or knee PJI caused by Staphylococcus spp and treated by the DAIR strategy (see Interventions), are eligible for inclusion. The diagnosis of PJI is defined according to the EBJIS 2021 criteria. Exclusion criteria are a contra-indication for rifampicin (due to a resistant strain, a proven allergic reaction, difficult drug-drug-interactions or other contra-indications as listed in the SmPC's of the antibiotics), a contra-indication for levofloxacin and clindamycin and cotrimoxazole and tetracyclines (due to a resistant strain, a proven allergic reaction, difficult drug-drug-interactions or other contra-indications as listed in the SmPC's of the antibiotics), (iii)complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment \> 3 weeks , (iv) 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), (v) treatment failure before the start of oral therapy, (vi) more than two separate surgical debridements , (vii)an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (viii) patients with an expected life expectancy \<12 months, (ix) patients with a tumor prosthesis , (x) patients receiving chemotherapy for active malignancy in the next 12 months, (xi) patients who are scheduled in advance for chronic suppressive antibiotic therapy after the initial 12 weeks of antibiotic treatment, (xii) The patient is unlikely to comply with trial requirements following randomization in the opinion of the investigator, (xiii) Pregnancy or breastfeeding, (xiv) Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study.
The main trial endpoint is treatment success 15 months after DAIR (=1 year after finishing antibiotic 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
Secondary outcomes are (a) Quality of life, measured with the 5-level EQ-5D version (EQ-5D-5L) questionnaires. The EQ-5D-5L is a standardized and validated measure of health status developed by the EuroQol Group to provide a comprehensive generic measure of health for clinical and economic appraisal. This 'quality of life' questionnaire will be scored at the time of randomization, at week 6 after the initial surgical debridement and after 3 months.
(b) Adverse events. The number of SAEs during antimicrobial treatment and follow up ii. The number of switches to a different oral regimen, iii. The number of antibiotic associated AEs (classified by the modified Hartwig and Siegel scale). (c) The number of patients developing Clostridioides difficile infection during treatment. (d) The occurrence of rifampicin resistance in bacteria in patients with a microbiologically confirmed failure of treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral rifampicin-based combination therapy
rifampicin 450mg BID + levofloxacin 500mg BID in the oral treatment phase with a total duration of antibiotics of 12 weeks
Rifampicin and levofloxacin
antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
Oral monotherapy with clindamycin
clindamycin 600mg TID in the oral treatment phase with a total duration of antibiotics of 12 weeks
Clindamycin
antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
Interventions
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Clindamycin
antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
Rifampicin and levofloxacin
antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Frisius Medisch Centrum
OTHER
Isala
OTHER
Martini Hospital Groningen
OTHER
Radboud University Medical Center
OTHER
Sint Maartenskliniek
OTHER
Elisabeth-TweeSteden Ziekenhuis
OTHER
Erasmus Medical Center
OTHER
Alrijne Hospital
OTHER
Spaarne Gasthuis
OTHER
Reinier Haga Orthopedisch Centrum
OTHER
Tergooi Hospital
OTHER
Rijnstate Hospital
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Mark de Boer MD PhD
Prof dr MGJ de Boer
Principal Investigators
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Henk Scheper, MD
Role: STUDY_DIRECTOR
LUMC
Locations
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LUMC
Leiden, Zuid Hollans, 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
Countries
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Central Contacts
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Facility Contacts
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Henk Scheper, MD PhD
Role: primary
Edgar Peters
Role: primary
Rudolf Poolman
Role: primary
Bas ten Have
Role: primary
Marjan Wouthuyzen-Bakker
Role: primary
Peter Nolte
Role: primary
Wierd Zijlstra
Role: primary
Rachid Mahdad
Role: primary
Wim Rijnen
Role: primary
Karn Veerman
Role: primary
Koen Bos
Role: primary
Olav van der Jagt
Role: primary
Jolanda Lammers
Role: primary
References
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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.
Related Links
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Website with information for patients and physicians about RiCOTTA study
Other Identifiers
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2022-501620-26-00
Identifier Type: -
Identifier Source: org_study_id