Ongoing Clinical Trials for Prosthetic Joint Infections
This article describes an ongoing clinical trial for patients with prosthetic joint infections caused by Staphylococcus aureus bacteria affecting the hip or knee. The trial is testing an innovative treatment approach using bacteriophages (viruses that target and kill specific bacteria) combined with standard antibiotic therapy and surgical cleaning of the infected joint. (Also known as: Arthritis infective, Infected prosthetic joint, PJI)
Clinical trial locations
Study of PP1493 and PP1815 bacteriophages combined with DAIR and antibiotics for treating knee or hip prosthetic joint infections caused by Staphylococcus aureus
This trial is being conducted in France and focuses on treating infections that occur in artificial hip or knee joints. These infections are caused by bacteria called Staphylococcus aureus and typically develop at least one month after joint replacement surgery.
Who can participate:
- Adults aged 18 years or older with health insurance coverage
- Patients who have a confirmed infection in their hip or knee joint caused by Staphylococcus aureus, diagnosed within the past 6 months
- The infection must have occurred more than one month after the joint replacement surgery
- The bacterial strain causing the infection must respond to at least one of the study treatments
- Patients must have a life expectancy of at least 2 years as determined by their doctor
- Women of childbearing age must have a negative pregnancy test and agree to use effective birth control methods for one month after the last study treatment
Who cannot participate:
- People under 18 years old
- Patients with known allergies to Staphylococcus aureus bacteriophages
- Pregnant or breastfeeding women
- Patients whose infection occurred less than one month after their joint replacement surgery
- Patients with infections caused by bacteria other than Staphylococcusaureus
- People who cannot receive standard antibiotic treatment or have severe immune system disorders
- Patients who have already undergone revision surgery (replacement of the infected joint)
- Those who participated in another clinical trial within the last 30 days
What the trial involves:
The main goal of this study is to test a new treatment approach that combines bacteriophages with standard care. Bacteriophages are special viruses that target and destroy specific bacteria without harming human cells. In this trial, researchers are testing two experimental bacteriophage treatments called PP1493 and PP1815.
All patients in the study will undergo a surgical procedure called DAIR (Debridement, Antibiotics, and Implant Retention), which involves cleaning the infected joint area while keeping the artificial joint in place. During this procedure, patients will receive either the bacteriophage treatment or a salt water solution (sodium chloride) through injection or infusion directly into the infected joint. Everyone will also receive standard antibiotic therapy to fight the infection.
After the initial treatment, the medical team will monitor your recovery by checking for signs of improvement such as absence of fever (temperature below 38°C), no worsening joint pain, no swelling around the joint, and proper healing of the surgical site. Blood tests will be performed regularly to monitor your overall health status. You will also be asked to complete quality of life questionnaires during your visits. If you have a knee replacement, you will complete the KOOS-12 survey, and if you have a hip replacement, you will complete the HOOS-12 survey.
The study aims to determine whether bacteriophage therapy, when combined with standard treatment, can effectively control the infection and prevent it from returning. Patients will be followed for several months to assess their recovery and monitor any potential side effects.
Summary
Currently, there is one ongoing clinical trial for patients with prosthetic joint infections caused by Staphylococcus aureus bacteria. This trial is being conducted in France and represents an innovative approach to treating these challenging infections. The study combines an experimental therapy using bacteriophages with standard surgical and antibiotic treatments. Bacteriophage therapy is an emerging field that offers potential benefits, particularly for infections that may be difficult to treat with antibiotics alone. This trial specifically targets infections occurring more than one month after joint replacement surgery, focusing on hip and knee joints. The research may provide valuable information about alternative treatment options for patients dealing with prosthetic joint infections.
