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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Stichting OLVG Amsterdam The Netherlands

Other Sites

Site Name City Country Status
Academisch Ziekenhuis Leiden Leiden The Netherlands
Medisch Centrum Leeuwarden B.V. Leeuwarden The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Amphia Hospital Breda The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Gelre Hospitals Zutphen The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Sint Maartenskliniek Stichting Ubbergen The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
MUMC+ Maastricht The Netherlands
Ssf Enqvuhmui Hlyrgwjn Twhoiab Tilburg The Netherlands
Rrgbxlk Hhwb Gccpj Ooflzfgwdjns Clifnzz Bhsw Zoetermeer The Netherlands
Egmwknj Uaefzdogarbj Misecey Cayeqch Rpekcnesq (qhwrlgx Mzu Rotterdam The Netherlands
Auzebnpxv Ulg Amsterdam The Netherlands
Rgozvqiad Zecnuluqqy Spcftjlrv Arnhem The Netherlands
Udnwwhmcsoqt Mthotwe Cscfoyj Gttefrvkq Groningen The Netherlands
Smcjpnpjz Movyoor Zlpvvqjwju Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.03.2023

Trial locations

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.

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 ID:
2022-501620-26-00
Protocol code:
2022-501620-26-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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