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The RiCOTTA study: Rifampicin Combination Therapy versus Targeted Antibiotic Monotherapy for Infected Joint Prostheses Caused by Staphylococci
EU CTIS ID: 2022-501620-26-00
What this study is testing
To establish whether targeted monotherapy with clindamycin for PJI in the oral treatment phase is non-inferior to traditional rifampicin/fluoroquinolones combination treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All adult patients, aged 18 years or older AND
- Diagnosed and hospitalized with hip- or knee prosthetic joint infection caused by Staphylococcus spp AND
- Treated with DAIR: Debridement, Antibiotics and Implant Retention
You likely can't join if
- a contra-indication for rifampicin (e.g. a resistant strain or proven allergic reaction or difficult drug-drug-interactions)
- The patient is unlikely to comply with trial requirements following randomization in the opinion of the investigator
- Pregnancy
- Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study
- 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)
- complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment > 2 weeks
See the full eligibility criteria
- All adult patients, aged 18 years or older AND
- Diagnosed and hospitalized with hip- or knee prosthetic joint infection caused by Staphylococcus spp AND
- Treated with DAIR: Debridement, Antibiotics and Implant Retention
- a contra-indication for rifampicin (e.g. a resistant strain or proven allergic reaction or difficult drug-drug-interactions)
- The patient is unlikely to comply with trial requirements following randomization in the opinion of the investigator
- Pregnancy
- Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study
- 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)
- complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment > 2 weeks
- treatment failure before the start of oral therapy
- an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21
- patients with an expected life expectancy <12 months
- patients with a tumor prosthesis
- patients receiving chemotherapy for active malignancy in the next 12 months
- patients who are scheduled in advance for chronic suppressive antibiotic therapy after the initial 12 weeks of antibiotic treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.