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Study Comparing Clindamycin to Rifampicin and Drug Combination for Patients with Prosthetic Joint Infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial, known as the RiCOTTA trial, is focused on studying the treatment of prosthetic joint infection, which is an infection that can occur in people who have had joint replacement surgery, such as a hip or knee replacement. The study is comparing two different treatment approaches during the oral medication phase. One approach uses a single medication called clindamycin, while the other uses a combination of medications, including rifampicin and a group of antibiotics known as fluoroquinolones. The goal is to determine if the single medication approach is as effective as the combination treatment.

Participants in the study will receive one of these treatments after undergoing a procedure called DAIR, which stands for Debridement, Antibiotics, and Implant Retention. This procedure involves cleaning the infected area, using antibiotics, and keeping the joint implant in place. The study will follow participants for a period of time to monitor their recovery and check for any signs of infection returning. The effectiveness of the treatment will be assessed 15 months after the DAIR procedure, which is one year after finishing the antibiotic treatment.

Throughout the study, various aspects will be evaluated, such as the participants' quality of life, any side effects from the antibiotics, and the occurrence of any new infections. The study will also look at whether any bacteria develop resistance to rifampicin in cases where the treatment does not work as expected. The trial is expected to continue until 2028, with the aim of providing valuable information on the best treatment approach for prosthetic joint infections.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate.

    You will be assessed to ensure you meet the criteria for participation, which includes being an adult diagnosed with a hip or knee prosthetic joint infection caused by Staphylococcus bacteria and having undergone a procedure called DAIR (debridement, antibiotics, and implant retention).

  2. Step 2

    Randomization

    You will be randomly assigned to one of two treatment groups. One group will receive a combination of rifampicin and fluoroquinolones, while the other group will receive clindamycin alone.

    This process ensures that each participant has an equal chance of receiving either treatment, which helps in comparing the effectiveness of the treatments.

  3. Step 3

    Treatment phase

    If you are in the combination therapy group, you will take rifampicin 300 mg capsules and a fluoroquinolone such as ciprofloxacin 500 mg film-coated tablets or levofloxacin 500 mg film-coated tablets orally. The specific dosage and frequency will be determined by the study team.

    If you are in the monotherapy group, you will take clindamycin 300 mg capsules orally. The specific dosage and frequency will be determined by the study team.

    The treatment will continue for a period specified by the study team, and you will be monitored regularly to assess your response to the treatment.

  4. Step 4

    Follow-up assessments

    You will have follow-up assessments to monitor your health and the effectiveness of the treatment. These assessments will occur at various intervals, including 6 weeks after surgical debridement and 3 months after starting the treatment.

    Your quality of life will be evaluated using a questionnaire called EQ-5D-5L, which measures different aspects of your well-being.

  5. Step 5

    End of trial evaluation

    The primary goal is to determine the success of the treatment 15 months after the DAIR procedure, which is 1 year after finishing the antibiotic treatment.

    Success is defined as the absence of infection-related re-surgery, no new antibiotic treatment for the joint, no ongoing use of antibiotics for the joint, and survival.

Who can join the trial?

3 criteria

  • All adult patients, aged 18 years or older
  • Diagnosed and hospitalized with hip or knee prosthetic joint infection caused by Staphylococcus spp (a type of bacteria)
  • Treated with DAIR: Debridement (cleaning out the infected area), Antibiotics, and Implant Retention (keeping the joint implant in place)

Who cannot join the trial?

3 criteria

  • Patients with a current or past history of prosthetic joint infection cannot participate. A prosthetic joint infection is an infection that occurs in the area where an artificial joint has been placed.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Rifampicin

    is a medication used to treat infections caused by bacteria. In this clinical trial, it is being used in combination with other antibiotics to treat infections in people who have had joint replacement surgery. The goal is to see if this combination is effective in treating the infection during the oral treatment phase.

  • Clindamycin

    is an antibiotic that is being tested in this trial as a single treatment option for infections in people with joint replacements. The study aims to find out if using clindamycin alone is as effective as using a combination of antibiotics in treating these infections during the oral treatment phase.

  • Fluoroquinolones

    are a group of antibiotics that are often used with rifampicin to treat bacterial infections. In this trial, they are part of the combination therapy being compared to clindamycin alone. The researchers want to determine if the combination of rifampicin and fluoroquinolones is more effective than using clindamycin by itself in treating joint replacement infections.

What is already known about the treatment

  • Clindamycin

    Clindamycin is an antibiotic that is taken orally, usually in the form of a pill or liquid. It is currently being studied in clinical trials to determine its effectiveness in treating infections in people with prosthetic joints, specifically those caused by staphylococcal bacteria. The main use of clindamycin is to treat bacterial infections by stopping the bacteria from making proteins they need to grow, which helps to eliminate the infection. It belongs to a group of drugs known as lincosamide antibiotics.

  • Rifampicin

    Rifampicin is an antibiotic that is typically administered orally in capsule form. It is well-established in medical practice and literature for its use in treating various bacterial infections, including those associated with prosthetic joints. Rifampicin works by inhibiting the bacterial RNA polymerase enzyme, which is crucial for bacteria to make essential proteins, thereby stopping their growth. It is classified as a rifamycin antibiotic and is often used in combination with other antibiotics to enhance its effectiveness.

Investigated diseases

Prosthetic Joint Infection – Prosthetic joint infection occurs when bacteria or other microorganisms infect the area around an artificial joint implant. This infection can develop shortly after surgery or even years later. It typically begins with pain and swelling in the joint area, often accompanied by redness and warmth. As the infection progresses, it may lead to joint stiffness and reduced mobility. In severe cases, the infection can cause the implant to loosen, leading to joint instability. The condition requires careful management to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501620-26-00Protocol code2022-501620-26-00Estimated enrolment317 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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