Ongoing Clinical Trials for Device Related Infection
This article describes 4 ongoing clinical trials focused on device related infections, including prosthetic joint infections and infections associated with bone implants and dialysis access. These trials are testing various antibiotics and treatment strategies, such as rifabutin versus rifampicin for joint infections, autovaccines compared to antibiotics, different durations of antimicrobial therapy for bone implant infections, and cefazolin dosing in dialysis patients.
Clinical trial locations
- France
- Spain
Study Comparing Rifabutin and Rifampicin for Adults with Staphylococcal Prosthetic Joint Infection Using DAIR Strategy
This trial is taking place in France and focuses on treating infections that occur in artificial joints, specifically those caused by staphylococcus bacteria. The study compares two antibiotics: rifabutin and rifampicin, both taken as oral capsules.
Who can participate: Adults aged 18 or older with a hip or knee prosthetic joint infection caused by staphylococcus bacteria are eligible. The infection must be treated using the DAIR strategy, which involves cleaning the infected area, starting antibiotics, and keeping the artificial joint in place. Patients must have received at least 2 days of appropriate antibiotics and must have French social insurance. Women who can become pregnant must use effective contraception.
Who cannot participate: The trial excludes patients under 18, those without staphylococcal infections, patients not being treated with the DAIR strategy, those with infections caused by other bacteria, patients unable to take oral medications, and vulnerable populations requiring special protection.
Main goal: The study aims to determine whether rifabutin is as effective as rifampicin in treating these infections. Both medications work by stopping bacterial growth. Participants receive treatment for up to 12 weeks and are monitored for one year to assess treatment success and side effects. The trial also evaluates quality of life and joint function over a period of up to two years.
Study on the Effectiveness of Autovaccines Compared to Antibiotics for Patients with Hip or Knee Prosthesis Infections
This Spanish trial explores a novel approach to managing infections in patients with hip or knee prostheses when a cure is not possible. It compares autovaccines with standard antibiotic treatment.
Who can participate: Patients over 18 years of age with a hip or knee prosthesis and an active infection that cannot be completely cured are eligible. The infection must be caused by only one type of bacteria. Participants must sign an informed consent form.
Who cannot participate: The trial specifically excludes patients with hip or knee infections, though this appears to refer to certain types or stages of infection not suitable for the study approach.
Main goal: The study evaluates whether autovaccines, which are personalized vaccines made from bacteria taken from the patient’s own infection, can help reduce symptoms like pain, redness, and wound drainage. The autovaccines are placed under the tongue for absorption. The antibiotic group receives medications such as fluconazole, sulfamethoxazole and trimethoprim, amoxicillin, metronidazole, ciprofloxacin, clindamycin, doxycycline, or linezolid. Treatment lasts up to 12 weeks, with monitoring for safety and effectiveness in controlling infection symptoms.
Study on the Effectiveness of Moxifloxacin and Drug Combination for Treating Bone Implant Infections in Patients with Long Bone Fractures
Conducted in Spain, this trial investigates the optimal duration of antibiotic treatment for infections related to the metal or other materials used to stabilize bone fractures.
Who can participate: Patients must be at least 14 years old with a stabilized fracture and a controlled infection that occurred either early (within 2-3 weeks after implant surgery) or delayed (between 3-10 weeks after surgery). The infection must be treatable with available antibiotics, and there should be no exposed bone. Participants must sign informed consent, and minors need guardian consent as well. Those who could become pregnant or father a child must use effective birth control during the trial.
Who cannot participate: The trial excludes patients without infections related to bone stabilization material, those not undergoing surgical cleaning of the infected area, and patients not receiving targeted antimicrobial therapy for long bone fractures.
Main goal: The study compares shorter versus longer courses of antibiotic treatment to determine if a shorter duration is equally effective. Antibiotics studied include moxifloxacin, amoxicillin sodium, daptomycin, cloxacillin, ampicillin, vancomycin, sulfamethoxazole, trimethoprim, meropenem, rifampicin, ceftriaxone, ciprofloxacin, linezolid, clindamycin, teicoplanin, ceftazidime, cefepime, and levofloxacin. These medications are given either orally or intravenously. The trial monitors infection resolution, development of new infections, need for additional surgeries, and overall recovery of limb function and quality of life. The study is expected to continue until the end of 2027.
Study of Cefazolin for Patients on Chronic Hemodialysis with Infections
This French trial focuses on patients undergoing long-term dialysis treatment who develop infections. It examines how the antibiotic cefazolin behaves in the body of these patients.
Who can participate: Adults aged 18 or older who are on chronic intermittent dialysis and need cefazolin treatment for infections are eligible. This includes infections possibly caused by methicillin-sensitive Staphylococcus aureus or bloodstream infections caused by certain bacteria called Gram-positive cocci. Patients must be able to provide blood samples from their arm or dialysis machine until their next dialysis session 48 hours later. They must have social security coverage and sign an informed consent form.
Who cannot participate: The trial excludes patients not on chronic hemodialysis, those without infections, patients outside the specified age range, and vulnerable populations.
Main goal: The study aims to understand how cefazolin is processed in the body of dialysis patients, specifically monitoring how long the medication stays in the bloodstream at effective levels. This information will help determine the best way to use cefazolin in treating infections in these patients. The trial monitors both early effectiveness (one week after starting treatment) and late effectiveness (six weeks after starting treatment), as well as any side effects occurring within six weeks after the last dose. Cefazolin is given through injection.
Summary
These four clinical trials address different aspects of device related infections, with a particular focus on prosthetic joint infections and implant-associated infections. Two trials are being conducted in France and two in Spain, suggesting active research interest in both countries.
The trials explore diverse treatment approaches, ranging from comparing different antibiotics (rifabutin versus rifampicin) to investigating novel immunotherapies (autovaccines). A common theme is optimizing treatment strategies, whether through selecting the most effective antibiotic, determining the optimal treatment duration, or finding alternatives to traditional antibiotic therapy for infections that cannot be completely cured.
The Spanish trials appear to focus on alternative or optimized approaches, including personalized autovaccine therapy and determining shorter treatment durations for bone implant infections. The French trials examine antibiotic optimization in specific patient populations, including dialysis patients and those with prosthetic joint infections. Together, these studies reflect ongoing efforts to improve outcomes for patients with challenging device related infections.
