Clinical Trials for Medical Device Site Joint Infection
Currently, there are 9 ongoing clinical trials focused on infections that occur around joint replacement implants in the hip, knee, or shoulder. These studies are testing new treatment approaches including antibiotics, bacteriophage therapy, diagnostic imaging techniques, and infection prevention strategies. Trials are being conducted across several European countries including the Netherlands, Belgium, Spain, Sweden, and France.
Clinical trial locations
- Belgium
- France
- Study on the Effects of Rifampicin, Amoxicillin, and Moxifloxacin in Treating Prosthetic Joint Infections Caused by Cutibacterium acnes for Affected Patients
- Study of PP1493 and PP1815 phage therapy for patients with knee or hip joint infections caused by Staphylococcus aureus after prosthetic surgery
- Study on the Impact of Cefepime, Piperacillin-Tazobactam, and Ceftobiprole on Gut Health in Patients with Bone and Joint Infections on Implants
- Study on the Use of Gallium Citrate Ga-68 for Diagnosing Chronic Infections in Artificial Hip and Knee Joints
- Netherlands
- Spain
- Sweden
Study Comparing Clindamycin to Rifampicin and Drug Combination for Patients with Prosthetic Joint Infection
This trial, known as the RiCOTTA study, is taking place in the Netherlands and compares two different oral antibiotic approaches for treating infections in hip or knee replacements.
Who can participate: Adults aged 18 or older who have a hip or knee prosthetic joint infection caused by Staphylococcus bacteria and have undergone a DAIR procedure. DAIR stands for debridement (cleaning the infected area), antibiotics, and implant retention (keeping the joint implant in place).
Who cannot participate: Patients with a current or past history of prosthetic joint infection, those outside the specified age range, or individuals who are part of vulnerable populations.
Main goal: The study aims to determine if treatment with clindamycin alone is as effective as the combination of rifampicin and fluoroquinolones during the oral medication phase. The primary measure of success will be assessed 15 months after the DAIR procedure, which is one year after finishing antibiotic treatment. Success means no infection-related re-surgery, no new antibiotic treatment for the joint, no ongoing antibiotic use, and survival.
Medications being tested: One group receives rifampicin 300 mg capsules combined with a fluoroquinolone such as ciprofloxacin 500 mg or levofloxacin 500 mg. The other group receives clindamycin 300 mg capsules as a single treatment. All medications are taken orally, and the study team will determine the specific dosage and frequency for each participant.
Study on Clindamycin and Rifampicin for Treating Infections in Patients with Obesity, Fracture-Related Infections, Hidradenitis Suppurativa, or Prosthetic Joint Infections
This trial is being conducted in Belgium and examines how clindamycin is processed in the body when used alone or in combination with rifampicin.
Who can participate: Adults aged 18 or older who have provided informed consent and meet specific requirements including BMI criteria. Participants must have started treatment with clindamycin alone or in combination with rifampicin, have a positive culture of Staphylococcus bacteria sensitive to both clindamycin and rifampicin, and be admitted to the orthopedic, traumatology, or dermatology ward. Women of childbearing potential must use highly effective birth control methods.
Who cannot participate: Patients with fracture-related infections, hidradenitis suppurativa, prosthetic joint infections, or those who are part of vulnerable populations.
Main goal: The study aims to understand how the body absorbs and processes clindamycin, especially in people with different body weights. It evaluates pharmacokinetic parameters such as the area under the curve, volume of distribution, clearance, and elimination half-life. The study also assesses treatment effectiveness and achieving a clinical cure over a period of up to 12 weeks.
Medications being tested: Clindamycin is administered orally, either alone or in combination with rifampicin. The study examines how rifampicin affects the way clindamycin is absorbed and processed in the body.
Study on Infection Prevention in Joint Replacement Surgery Using Povidone, Chlorhexidine, and Vancomycin for Adult Patients
This Spanish trial explores new treatments to prevent infections after total joint replacement surgery in the hip or knee.
Who can participate: Adults aged 18 or older who are undergoing primary or aseptic revision total joint replacement surgery. Aseptic revision means replacing a joint that is not infected.
Who cannot participate: Patients under 18 years old, those not undergoing TJR surgery, or individuals who are part of vulnerable populations.
Main goal: The study compares different solutions used during surgery to determine if they can reduce the risk of infection within 12 months after the procedure. The main objective is to see if these treatments can lower the chances of needing another surgery due to infection.
Medications being tested: Three different approaches are being evaluated: povidone-iodine irrigation solution, chlorhexidine irrigation solution, and vancomycin applied locally during surgery. These are compared to a standard saline solution. Before surgery, patients receive a chlorhexidine solution for skin preparation. During surgery, the irrigation solution and possibly vancomycin are applied to clean the surgical area and help prevent infection.
Study on Reducing Prosthetic Joint Infection in Hip Replacement Patients Using Vancomycin, Tobramycin, and Saline-Infused Bone Graft
This Swedish study, known as the ABOGRAFT trial, investigates whether using an antibiotic-treated bone graft can reduce infection risk after hip replacement surgery.
Who can participate: Adults aged 18 or older who need a hip replacement with a bone graft and provide informed consent. Women of childbearing potential must have a negative pregnancy test before the reoperation.
Who cannot participate: Patients not within the specified age range or those who are part of vulnerable populations.
Main goal: The study aims to determine if using an antibiotic impregnated bone graft can reduce the risk of infection two years after hip replacement surgery. Researchers will monitor participants for any signs of infection or need for additional surgery in the same hip joint within two years, as well as the time and reasons for any further surgeries or implant revisions within two to five years.
Medications being tested: The antibiotics vancomycin and tobramycin are administered directly into the joint area during surgery through a method called intraarticular use. The bone graft is either impregnated with these antibiotics or a placebo, and this is compared between two groups to assess effectiveness in preventing infections.
Study on the Effects of Rifampicin, Amoxicillin, and Moxifloxacin in Treating Prosthetic Joint Infections Caused by Cutibacterium acnes for Affected Patients
This French trial examines the safety and effectiveness of rifampicin in treating infections caused by Cutibacterium acnes in people who have had joint replacement surgery.
Who can participate: Adults aged 18 or older with a monomicrobial infection caused by Cutibacterium acnes in a prosthetic joint (knee, hip, or shoulder). The infection must be susceptible to rifampicin and treated surgically with either a single-stage or two-stage revision. The presence of the bacteria must be confirmed in two separate samples taken during surgery, and based on susceptibility tests and medical history, the infection should be treatable with either amoxicillin or moxifloxacin.
Who cannot participate: Patients with serious infections not related to the study, allergies to study medications, those currently in another clinical trial, patients with liver or kidney disease, pregnant or breastfeeding women, those with a history of drug or alcohol abuse, patients who had major surgery within the last 30 days, those with immune system disorders, or patients unable to follow study procedures.
Main goal: The study aims to understand how safe and effective rifampicin is when used to treat Cutibacterium acnes prosthetic joint infections. Participants receive treatment for up to 12 weeks, and the study monitors for any signs of infection returning, new infections developing, or side effects from the medications. Follow-up continues for up to 24 months to assess long-term outcomes.
Medications being tested: Rifampicin is compared with other antibiotics including amoxicillin, moxifloxacin, clindamycin, and doxycycline. Rifampicin works by stopping bacteria from making essential proteins, thereby killing the bacteria and clearing the infection. It is often used in combination with other antibiotics to enhance effectiveness and prevent bacterial resistance.
Study on the Use of Gallium Citrate Ga-68 for Diagnosing Chronic Infections in Artificial Hip and Knee Joints
This French trial investigates the use of a special imaging technique to help diagnose infections in artificial hip or knee joints.
Who can participate: Adults over 18 years old visiting a specialized center for joint prosthesis infection for the first time due to a suspected infection of an artificial hip or knee that started at least one month before. Patients must undergo routine diagnosis including screening by both bone scintigraphy and polynuclear scintigraphy, have a positive bone scintigraphy result, be affiliated with a health insurance system, and have signed an informed consent form.
Who cannot participate: Patients who do not have a prosthetic joint infection, those not within the specified age range, or individuals who are part of vulnerable populations.
Main goal: The study aims to determine how accurate the 68 Gallium citrate PET/CT scan is in diagnosing chronic infections in artificial hip or knee joints. Researchers will assess the accuracy by looking at its ability to correctly identify infections and examine how consistent the results are when interpreted by different observers. The study will also compare results with another imaging method called marked polynuclear scintigraphy.
Medications being tested: 68 Gallium citrate is a substance injected intravenously that helps create detailed images during PET/CT scans. It binds to areas of infection, allowing them to be visualized and potentially improving diagnosis of prosthetic joint infections.
Study of PP1493 and PP1815 phage therapy for patients with knee or hip joint infections caused by Staphylococcus aureus after prosthetic surgery
This international trial, conducted in France, Spain, and the Netherlands, evaluates a new treatment approach using bacteriophages to treat infections around hip or knee joint replacements.
Who can participate: Adults at least 18 years old with a hip or knee joint infection caused by Staphylococcus aureus bacteria, who have a life expectancy of more than 1 year and are eligible for a DAIR procedure. Women who cannot have children must be surgically sterilized or have not had menstrual periods for at least 12 months. Women who can have children must have a negative pregnancy test and, along with sexually active men, agree to use effective birth control methods until 1 month after the last study treatment. Participants must have a single bacterial infection, health insurance or affiliation with a national social security system, and must sign an informed consent form.
Who cannot participate: Patients under 18 years old, those with infections not caused by Staphylococcus aureus or in joints other than hip or knee, patients without prosthetic joint infection or who cannot undergo DAIR procedure, pregnant or breastfeeding women, those with known allergies to study medications, patients currently participating in other clinical trials, those unable to provide informed consent, patients with severe immune system disorders or conditions that could interfere with study follow-up, and patients who received antibiotics within 48 hours before the study start.
Main goal: The study evaluates if adding bacteriophage therapy to standard DAIR treatment is safe and effective for treating prosthetic joint infections. Bacteriophages are viruses that specifically target and destroy Staphylococcus aureus bacteria. The study monitors patients for three months to assess their response to treatment, tracking infection healing and any side effects.
Medications being tested: PP1493 and PP1815 are bacteriophage solutions administered through intra-articular injection directly into the joint during the DAIR procedure. These are compared to a placebo treatment, with both groups also receiving standard surgical care. The treatment period lasts for three days, with follow-up evaluations continuing for several months.
Study on Antibiotic Treatment for Hip and Knee Joint Infections Using Linezolid, Fusidic Acid, and Rifampicin
This Swedish trial evaluates how different antibiotics work in treating infections around artificial joints in the hip and knee.
Who can participate: Adults with a first-time mono-microbial staphylococcal infection in the hip or knee joint (meaning an infection caused by a single type of staphylococcus bacteria). Patients must have undergone a DAIR procedure, received 14 days of intravenous treatment with either cloxacillin or vancomycin, and had standardized administration of local antibiotics.
Who cannot participate: Patients with periprosthetic hip joint infection or periprosthetic knee joint infection.
Main goal: The study aims to determine if using Minimum Biofilm Eradication Concentration testing along with Minimum Inhibitory Concentration testing can help guide treatment more effectively. Biofilms are protective layers that bacteria form, making infections harder to treat. The study will compare how these methods affect infection resolution, drug tolerance, and bacterial resistance patterns. Participants will be observed for up to 12 months to track outcomes such as the need for additional procedures, infection recurrence, and overall health status.
Medications being tested: The antibiotics being studied include linezolid, fusidic acid, rifampicin, levofloxacin, sulfamethoxazole and trimethoprim, and clindamycin. Participants take these oral antibiotics, with the specific dosage and frequency determined by the healthcare provider based on test results showing how well the antibiotics can eliminate bacteria in biofilms.
Study on the Impact of Cefepime, Piperacillin-Tazobactam, and Ceftobiprole on Gut Health in Patients with Bone and Joint Infections on Implants
This French trial examines how different antibiotic treatments affect the bacteria in the digestive system of patients with bone and joint infections involving medical equipment.
Who can participate: Adults aged 18 or older who need prosthetic revision (replacing or fixing a joint replacement), total shoulder prosthesis, or revision of internal osteosynthesis material (fixing or replacing metal parts used to hold bones together) with a suspicion of infection in the bones or joints related to medical equipment. Participants must have a normal creatine phosphokinase blood test level according to laboratory standards. Both men and women can participate, and they should not be from vulnerable populations.
Who cannot participate: Patients with bone or joint infections involving medical devices, those not within the specified age range, or individuals who are part of vulnerable populations.
Main goal: The study aims to understand how different antibiotic treatments impact the variety of bacteria in the gut over a short period, specifically from the first day to the fifth day of treatment. This is important because antibiotics can sometimes disrupt the balance of gut bacteria, which can lead to other health issues. The diversity of gut bacteria will be analyzed using 16S rDNA metagenomics, a method to study bacterial genetic material.
Medications being tested: The antibiotics include cefepime combined with daptomycin, piperacillin-tazobactam combined with daptomycin, or ceftobiprole alone. These medications are administered through intravenous infusion directly into a vein for a maximum of five days. The study will help determine which antibiotic or combination is most effective while having the least impact on gut bacteria.
Summary
The nine ongoing clinical trials for medical device site joint infections demonstrate a comprehensive approach to addressing this serious complication. France leads with four trials, followed by Sweden with two, while Belgium, Spain, and the Netherlands each host one or more studies. A notable international collaboration involves the bacteriophage therapy trial, which spans France, Spain, and the Netherlands.
The trials show diverse research directions. Several studies focus on optimizing antibiotic regimens, particularly examining rifampicin combinations and their alternatives. The Swedish trials uniquely investigate biofilm-specific treatment approaches and antibiotic-impregnated bone grafts. Innovation is evident in the French bacteriophage therapy trial, representing a cutting-edge approach to antibiotic-resistant infections.
Most trials target Staphylococcus infections, the most common cause of prosthetic joint infections, though one French study specifically addresses Cutibacterium acnes. The predominance of hip and knee joint infections reflects the high volume of these replacement procedures. Research spans from prevention strategies during initial surgery to treatment of established chronic infections, with several studies focusing on patients undergoing DAIR procedures.
The trials employ varied methodologies including antibiotic comparisons, diagnostic imaging improvements, microbiome impact assessments, and novel biological therapies. Follow-up periods range from 3 months to 5 years, with most studies tracking participants for 12-24 months to assess long-term outcomes and infection recurrence rates.
