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Study of PP1493 and PP1815 phage therapy for patients with knee or hip joint infections caused by Staphylococcus aureus after prosthetic surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with prosthetic joint infection in the hip or knee caused by Staphylococcus aureus bacteria. The infection occurs around artificial joint implants and requires medical intervention. The study evaluates a new treatment approach using bacteriophages (viruses that target specific bacteria) in combination with a standard surgical procedure called DAIR (debridement, antibiotics, and implant retention).

The treatment being tested includes two investigational products, PP1493 and PP1815, which are bacteriophage solutions given through intra-articular injection (injection directly into the joint). These will be compared to a placebo treatment, with both groups also receiving standard surgical care. The study aims to determine if adding bacteriophage therapy to standard treatment is safe and effective for treating prosthetic joint infections.

The study will monitor patients for three months to assess their response to treatment. Participants will receive either the bacteriophage treatment or placebo, along with standard care. During the study, doctors will track the healing of the infection and monitor for any side effects. The treatment period lasts for three days, with follow-up evaluations continuing for several months to ensure patient safety and assess treatment effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and qualification

    You will be evaluated for hip or knee joint infection caused by a bacteria called Staphylococcus aureus

    Medical team will confirm if your case qualifies for the DAIR procedure (cleaning of the infected joint area)

    Basic health assessments will be performed, including blood tests and pregnancy test if applicable

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either the study medication (phage therapy) or placebo

    Neither you nor your doctor will know which treatment you are receiving

    The medication will be given through injection directly into the joint (intra-articular injection)

  3. Step 3

    DAIR procedure and treatment

    You will undergo the DAIR procedure to clean the infected joint area

    The study medication or placebo will be administered during this procedure

    Regular antibiotics will also be prescribed as part of standard treatment

  4. Step 4

    3-month follow-up period

    Regular check-ups will monitor your recovery and any possible side effects

    Blood tests and joint fluid samples will be taken

    X-rays will be performed to check the condition of your joint

    Quality of life questionnaires will need to be completed

  5. Step 5

    12-month follow-up period

    Continued monitoring of your joint infection recovery

    Additional blood tests and x-rays will be performed

    Final assessment of treatment effectiveness

    Monitoring for any long-term effects or complications

Who can join the trial?

14 criteria

  • Must be at least 18 years old
  • Must have a hip or knee joint infection caused by Staphylococcus aureus bacteria
  • Must have a life expectancy of more than 1 year
  • For women who cannot have children: must be either surgically sterilized or have not had menstrual periods for at least 12 months
  • For women who can have children: must have a negative pregnancy test
  • For women who can have children and sexually active men: must agree to use effective birth control methods until 1 month after the last study treatment. Acceptable methods include:
    • Hormonal contraception (pills, vaginal rings, or patches)
    • Progestogen-only contraception (pills, injections, or implants)
    • Intrauterine devices
    • Sexual abstinence
    • Condom use for men with female partners who can become pregnant
    • Must have a single bacterial infection (not multiple types of bacteria)
    • Must be eligible for a surgical procedure called DAIR (cleaning of the infected joint)
    • Must have health insurance or be affiliated with a national social security system
    • Must sign an informed consent form before starting any study procedures

Who cannot join the trial?

12 criteria

  • Patients under 18 years old
  • Patients who have other types of infections not caused by Staphylococcus aureus (a specific type of bacteria)
  • Patients with infections in joints other than hip or knee
  • Patients who do not have a prosthetic joint infection (infection in artificial joint)
  • Patients who cannot undergo DAIR procedure (Debridement, Antibiotics, Implant Retention - a surgical cleaning of the infected joint)
  • Pregnant or breastfeeding women
  • Patients with known allergies to the study medications
  • Patients currently participating in other clinical trials
  • Patients unable to provide informed consent
  • Patients with severe immune system disorders
  • Patients with conditions that could interfere with study follow-up
  • Patients who received antibiotics within 48 hours before the study start
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Investigated drugs

Bacteriophage therapy is a treatment that uses specific viruses (called bacteriophages) to target and destroy harmful bacteria. In this trial, the bacteriophages are specifically designed to attack Staphylococcus aureus bacteria that cause infections in hip or knee joint replacements. DAIR (Debridement, Antibiotics, Implant retention) is a surgical procedure combined with antibiotic treatment. This approach involves cleaning the infected area around the artificial joint while keeping the prosthesis in place, followed by targeted antibiotic treatment. The trial combines these two treatments (bacteriophage therapy and DAIR) to evaluate if this combination is more effective than DAIR alone in treating prosthetic joint infections.

What is already known about the treatment

Bacteriophage Therapy - A specialized treatment approach using viruses (bacteriophages) that specifically target and eliminate Staphylococcus aureus bacteria in prosthetic joint infections of the hip or knee. This therapy is administered during the DAIR (Debridement, Antibiotics, Implant Retention) surgical procedure and works by directly attacking and destroying harmful bacteria while leaving human cells unaffected. Currently in Phase II clinical trials, this treatment represents an innovative approach to combating antibiotic-resistant infections, particularly in cases involving prosthetic joint infections. The therapy belongs to the class of biological anti-infective agents and shows promise as a targeted alternative to conventional antibiotics.

Investigated diseases

Prosthetic Joint Infection (PJI) caused by Staphylococcus aureus - A bacterial infection that occurs around artificial hip or knee joints after joint replacement surgery. The infection develops when Staphylococcus aureus bacteria colonize the area around the prosthetic joint, causing inflammation and damage to surrounding tissues. The condition typically causes pain, swelling, warmth around the joint, and reduced mobility of the affected limb. The infection can develop shortly after surgery or even years later, with symptoms sometimes developing gradually over time. The bacteria can form biofilms on the prosthetic surface, making the infection particularly challenging to address.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516555-40-00Protocol codeGLORIA - PP-SA-003Estimated enrolment85 patients

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