Study of PP1493 and PP1815 bacteriophages combined with DAIR and antibiotics for treating knee or hip prosthetic joint infections caused by Staphylococcus aureus

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What is this study about?

This study focuses on prosthetic joint infection affecting the hip or knee that is caused by bacteria called Staphylococcus aureus. This type of infection can occur more than one month after having a joint replacement surgery. The study will test a new treatment approach using bacteriophages (viruses that target and kill specific bacteria) in combination with standard antibiotic therapy.

The research will evaluate two experimental treatments called PP1493 and PP1815, which are special solutions containing bacteriophages that are given through injection or infusion. These will be compared to treatment with a sodium chloride solution (salt water). All patients in the study will also receive standard antibiotic treatment and a surgical procedure called DAIR (debridement, antibiotics, and implant retention) to clean the infected joint area.

The main goal is to determine how well these treatments control the infection by monitoring signs like fever, pain, and swelling around the joint. The study will track whether the infection goes away and stays away after treatment. Patients will be followed for several months to check their recovery and any potential side effects of the treatment.

1 Initial treatment

You will receive treatment through a DAIR procedure (debridement, antibiotics, and implant retention – a surgical cleaning of the infected joint prosthesis)

During this procedure, you will receive either bacteriophages (specialized viruses that target bacteria) or saline solution (0.9% sodium chloride)

The treatment will be administered as an injection or infusion directly into the affected joint area

2 Antibiotic therapy

You will receive antibiotic treatment to fight the infection

The antibiotics will be administered according to your specific treatment plan

3 Regular monitoring

Your joint infection will be monitored for signs of improvement

The medical team will check for: absence of fever (temperature below 38°C), no worsening joint pain, no swelling around the joint

The surgical site will be examined for proper healing without signs of inflammation or unusual discharge

Blood tests will be performed to monitor your health status

4 Quality of life assessment

You will complete quality of life questionnaires during your visits

If you have a knee replacement, you will complete the KOOS-12 survey

If you have a hip replacement, you will complete the HOOS-12 survey

5 Follow-up examinations

Regular examinations will check for proper positioning of your prosthesis

If needed, joint fluid samples may be taken to test for presence of infection

The total duration of your participation will be determined by your treatment response

Who Can Join the Study?

Age 18 years or older
Must have a negative pregnancy test if applicable
Must provide written informed consent before participating in any study procedures
Must have health insurance coverage
Must have a knee or hip joint infection caused by Staphylococcus aureus bacteria occurring more than 1 month after joint replacement surgery
The infection must be confirmed by joint fluid tests within the past 6 months
Must not have any other types of bacterial infections in the joint
The bacterial strain must respond to at least one of the study treatments
Must have a life expectancy of at least 2 years as determined by the doctor
If able to have children:
- Must agree to use effective birth control methods (such as oral contraceptives, implants, IUDs, or condoms) for 1 month after the last study treatment
Women who cannot have children must either:
- Have had surgical sterilization, or
- Be post-menopausal (no menstrual periods for at least 12 months)

Who Cannot Join the Study?

Age below 18 years old
Patients with known allergies to Staphylococcus aureus bacteriophages
Pregnant or breastfeeding women
Patients with prosthetic joint infection occurring less than 1 month after surgery
Presence of infections caused by bacteria other than Staphylococcus aureus (a type of bacteria commonly found on the skin)
Patients who cannot receive standard antibiotic therapy
Patients with severe immune system disorders
Previous participation in another clinical trial within the last 30 days
Inability to provide informed consent
Known hypersensitivity or allergic reactions to components used in the study treatment
Presence of other serious medical conditions that could interfere with study participation
Patients who have already undergone revision surgery for the infected joint

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Csdnnn Hbfmflweupx Rptcyrvy Usbtnfwzxskvd Dy Tqskd	Tours	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.06.2022

Trial locations

Investigated drugs:

Bacteriophages
These are viruses that specifically target and kill bacteria. In this trial, they are used to combat Staphylococcus aureus infections in patients with infected hip or knee prosthetic joints. Bacteriophages work by destroying harmful bacteria while leaving human cells unharmed.

Antibiotics
These are medications used to treat bacterial infections. In this trial, they are used in two forms: as a curative therapy during the initial treatment phase and as a suppressive therapy for long-term management of prosthetic joint infections.

DAIR
This stands for Debridement, Antibiotics, and Implant Retention. While not a medication, it is a surgical procedure combined with antibiotic treatment that involves cleaning the infected area while keeping the prosthetic joint in place. This therapy is used for managing prosthetic joint infections.

Investigated diseases:

Medical device site joint infection

Prosthetic Joint Infection (PJI) – A serious complication that occurs when bacteria infect the area around a prosthetic knee or hip joint. The infection typically develops after joint replacement surgery and can occur weeks, months, or even years after the procedure. In this condition, bacteria (particularly Staphylococcus aureus) colonize the artificial joint and surrounding tissues, leading to inflammation, pain, and reduced joint function. The infection can cause symptoms such as warmth around the joint, redness, swelling, and increased pain or difficulty moving the affected joint. PJI may also be accompanied by fluid accumulation around the prosthetic joint.

Trial ID:

2024-516207-17-00

NCT ID:

NCT05369104

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of PP1493 and PP1815 bacteriophages combined with DAIR and antibiotics for treating knee or hip prosthetic joint infections caused by Staphylococcus aureus

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?