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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

Verified siteRegistered drugNo placebo
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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 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.

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 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. Step 2

    Antibiotic therapy

    You will receive antibiotic treatment to fight the infection

    The antibiotics will be administered according to your specific treatment plan

  3. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

12 criteria

  • 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
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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.

What is already known about the treatment

  • Bacteriophages

    A naturally occurring virus that specifically targets and eliminates bacteria, administered through direct application to infected joint areas during DAIR (Debridement, Antibiotics, and Implant Retention) procedure. This experimental therapy is currently being investigated in clinical trials for treating prosthetic joint infections caused by Staphylococcus aureus bacteria. The mechanism of action involves the phages attaching to specific bacterial cells, injecting their genetic material, and causing bacterial cell destruction. This treatment represents a potential alternative or complementary approach to conventional antibiotic therapy, particularly in cases where antibiotic resistance is a concern.

  • Sodium Chloride 0.9%

    A sterile saline solution used as a control substance in clinical trials, administered directly to the infected joint area during DAIR procedure. This isotonic solution is widely used in medical practice as it matches the body's natural salt concentration and serves as a standard comparison agent in clinical studies. The solution acts as a neutral substance that helps maintain proper tissue hydration without directly affecting bacterial growth, making it an ideal control substance for evaluating the effectiveness of experimental treatments.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516207-17-00Estimated enrolment29 patientsSponsorPhaxiam Therapeutics

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).