Hip Prosthesis InfectionPhase 2GLORIANCT06605651
Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.
A Phase 2 study testing Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution and 0.9% NaCl solution in people with Hip Prosthesis Infection and Knee Prosthesis Infection, run by Phagenix.
Trial summary
Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Prosthesis Infection, Knee Prosthesis Infection
- What is being tested?
- Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution and 0.9% NaCl solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years
- Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines
- Monobacterial Infection due to S. aureus
- Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered at the end of the DAIR (presence of a contaminant is not considered clinically relevant)
- Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed during the DAIR if treatment is administered up to 14 days after the DAIR
- Indication for Open DAIR decided by the Multidisciplinary Team and/or Principal Investigator
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- S. aureus in joint fluid during the pre-inclusion period or in case of relapse of infection under antibiotics therapy in the last 6 months before inclusion
- Patient with a life expectancy of 1 year or more as determined by the principal investigator.
- Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable effective method of birth control until 1 month after the last study drug administration.
- Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
Who cannot join
- Relapse between DAIR and study drug administration planned up to 14 days after the DAIR.
- Patients who have two planned DAIR in sequence (double DAIR)
- Patients with ASA score ≥ 4
- Severe sepsis or Septic shock or hemodynamic instability
- Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation
- Indication for suppressive antibiotherapy
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- Immunosuppressed patients: Patients having a weakened immune system due to diseases conditions (i.e. genetic disorders, malnutrition) or treatment (i.e. anticancer drugs or organ transplant)
- Positive Human Immunodeficiency Viruses (HIV) test or active hepatitis B and C
- Previous treatment by bacteriophages
- Any known phage allergy and/or to its excipients
- Elevated ALT or AST above 4 times ULN
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Proof of Concept Multicenter, Randomized, Double-Blind Study to Assess the Safety and Efficacy of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated by DAIR
Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics. Standard treatment involves DAIR surgery and antibiotics, but there's a need for better solutions due to rising infections and antibiotic resistance. Bacteriophage therapy, which targets specific bacteria, shows promise. Phaxiam Therapeutics is studying the safety and efficacy of phage therapy in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.
Read the detailed description
Total joint replacement serves as valuable interventions in the management of chronic refractory pain when the other conservative treatments have not worked. They play a vital role in alleviating discomfort and improving the quality of life of subjects battling with joint diseases. However, the joint replacements present the challenge of Prosthetic Joint Infection (PJI). PJI have serious complications and can lead to significant mortality, morbidity, and healthcare expenditure.
The leading cause of PJI is gram-positive cocci, specifically Staphylococcus aureus. Bacterial biofilms, mainly formed with Staphylococcus, represent a significant challenge in the treatment of PJIs due to their resistance to antibiotic therapy. Standard of Care (SOC) for these complex infections is characterized primarily by an initial surgery (Debridment Antibiotics and Implant Retention (DAIR) and various regiments and combinations of antibiotics. While the patterns of utilization vary between institutions and geography, DAIR is considered low-invasive procedure, characterized by the possibility of not explanting the prosthetic implant and resecting the bone. The growing demand for joint arthroplasty and current PJI rates, combined with antibacterial resistance, clearly indicate an unmet medical need in treating biofilm-based PJIs.
Bacteriophage therapy could potentially improve the treatment paradigm for PJIs. Bacteriophages naturally occur with highly specific bacterial viruses that infiltrate bacterial cells, disrupting their metabolism, and causing bacterial lysis. Initial in vivo studies of phage therapy for bone-related infections have shown promise.
Phaxiam Therapeutics, a biotechnology company specializing in the research and development of anti-infective therapies using bacteriophages., has collections of phages against Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. These phages have shown promise in preliminary tests and studies.
The objective of GLORIA study Is to assess the safety and efficacy of phage therapy versus placebo in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.
- Being tested
- Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution, 0.9% NaCl solution
- Keywords
- Prosthetic Joint Infection, PJI, Bacteriophages, Phages, DAIR, Phage Therapy, Antimicrobials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solutionBiological
Three intra-articular injections during and/or following DAIR procedure
0.9% NaCl solutionDrug
Three intra-articular injections during and/or following DAIR procedure
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution Receives: Biological: Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution |
| Control Arm | Placebo comparator | 0.9% NaCl solution Receives: Drug: 0.9% NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of phage therapy + DAIR compared with placebo + DAIR
Incidence of serious adverse events
Measured: From enrollment up to 3 months
To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR
Percentage of patients with clinical cure
Measured: From enrollment up to 3 months
Secondary outcomes (10)
To assess the safety of phage therapy + DAIR compared with placebo + DAIR
Incidence of all adverse events and all safety parameters
Measured: From enrollment up to 12 months
To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR
Percentage of Patient with clinical cure from S.aureus's infection up to 6 months and up to 12 months. Percentage of patients with relapse exclusively due to another germ than Staphylococcus aureus up to 3 months, 6 months and 12 months
Measured: From enrollment up to 12 months
To describe the immunological response in serum and in joint fluid
Titration of anti-Staphylococcus aureus phage antibodies
Measured: From enrollment up to 3 months
To describe the S. aureus bacterial load (bacteriology) in the joint fluid up to 1 month
Quantitative or Semi-Quantitative analysis of bacterial load
Measured: From enrollment up to 1 month
To describe Cytology in the joint fluid
Quantification and identification of polynuclear of joint fluid
Measured: From enrollment up to 1 month
To describe the hospitalization duration
Number of hospitalizations
Measured: From enrollment up to 3 months and up to 12 months
To describe the hospitalization duration
Total duration of hospitalizations
Measured: From enrollment up to 3 months and up to 12 months
To describe the quality of life for patients
Results of quality-of-life questionnaires (EQ-5D-5L: EuroQol-5 Dimensions-5 Levels) from 0 (worst health you can imagine) to 100 (best health you can imagine)
Measured: From enrollment up to 3 months and up to 12 months
To describe joint function rehabilitation
Total score of either KOOS-12 (Knee Injury and Osteoarthritis Outcome Score 12 questions) OR HOOS-12 (Hip Injury and Osteoarthritis Outcome Score-12 questions) Questionnaires, depending on infected joint. The score is calculated in a scale from 0 (extreme symptoms) to 100 (absence of symptoms).
Measured: From enrollment up to 3 months and up to 12 months
To describe the evolution of the prosthetic joint infection by X Ray image
X Ray image analysis to detect the potential appearance of abnormal loosening (border with shifting of the prosthesis)
Measured: From screening up to 3 months and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study startJul 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Prosthesis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an international, multicentric, phase II (proof of concept), randomized, double-blind, parallel group, placebo-controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phagenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Chief Medical Officer, Study director, PhagenixAudrey Study Team Leader, Study director, Phagenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605651
- Sponsor's protocol ID
- PP-SA-003
- Other IDs
- 2024-516555-40-00
- Acronym
- GLORIA
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Proof of Concept Multicenter, Randomized, Double-Blind Study to Assess the Safety and Efficacy of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated by DAIR
- ClinicalTrials.gov ID
- NCT06605651
- Acronym / sponsor ID
- GLORIA / PP-SA-003
- Keywords
- Prosthetic Joint Infection, PJI, Bacteriophages, Phages, DAIR, Phage Therapy, Antimicrobials
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PhagenixIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics. Standard treatment involves DAIR surgery and antibiotics, but there's a need for better solutions due to rising infections and antibiotic resistance. Bacteriophage therapy, which targets specific bacteria, shows promise. Phaxiam Therapeutics is studying the safety and efficacy of phage therapy in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.
Detailed description
Total joint replacement serves as valuable interventions in the management of chronic refractory pain when the other conservative treatments have not worked. They play a vital role in alleviating discomfort and improving the quality of life of subjects battling with joint diseases. However, the joint replacements present the challenge of Prosthetic Joint Infection (PJI). PJI have serious complications and can lead to significant mortality, morbidity, and healthcare expenditure.
The leading cause of PJI is gram-positive cocci, specifically Staphylococcus aureus. Bacterial biofilms, mainly formed with Staphylococcus, represent a significant challenge in the treatment of PJIs due to their resistance to antibiotic therapy. Standard of Care (SOC) for these complex infections is characterized primarily by an initial surgery (Debridment Antibiotics and Implant Retention (DAIR) and various regiments and combinations of antibiotics. While the patterns of utilization vary between institutions and geography, DAIR is considered low-invasive procedure, characterized by the possibility of not explanting the prosthetic implant and resecting the bone. The growing demand for joint arthroplasty and current PJI rates, combined with antibacterial resistance, clearly indicate an unmet medical need in treating biofilm-based PJIs.
Bacteriophage therapy could potentially improve the treatment paradigm for PJIs. Bacteriophages naturally occur with highly specific bacterial viruses that infiltrate bacterial cells, disrupting their metabolism, and causing bacterial lysis. Initial in vivo studies of phage therapy for bone-related infections have shown promise.
Phaxiam Therapeutics, a biotechnology company specializing in the research and development of anti-infective therapies using bacteriophages., has collections of phages against Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. These phages have shown promise in preliminary tests and studies.
The objective of GLORIA study Is to assess the safety and efficacy of phage therapy versus placebo in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an international, multicentric, phase II (proof of concept), randomized, double-blind, parallel group, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Biological: Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solutionAnti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution |
| Control Arm | Placebo comparator | Drug: 0.9% NaCl solution0.9% NaCl solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female ≥ 18 years
- Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines
- Monobacterial Infection due to S. aureus
- Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered at the end of the DAIR (presence of a contaminant is not considered clinically relevant)
- Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed during the DAIR if treatment is administered up to 14 days after the DAIR
Key exclusion criteria (11 listed)
- Relapse between DAIR and study drug administration planned up to 14 days after the DAIR.
- Patients who have two planned DAIR in sequence (double DAIR)
- Patients with ASA score ≥ 4
- Severe sepsis or Septic shock or hemodynamic instability
- Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solutionThree intra-articular injections during and/or following DAIR procedure | Biological | Active Arm |
| 0.9% NaCl solutionThree intra-articular injections during and/or following DAIR procedure | Drug | Control Arm |
Primary outcome
To assess the safety of phage therapy + DAIR compared with placebo + DAIR
Time frame: From enrollment up to 3 months
Incidence of serious adverse events
To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR
Time frame: From enrollment up to 3 months
Percentage of patients with clinical cure
10 secondary outcomes
To assess the safety of phage therapy + DAIR compared with placebo + DAIR
Time frame: From enrollment up to 12 months
To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR
Time frame: From enrollment up to 12 months
To describe the immunological response in serum and in joint fluid
Time frame: From enrollment up to 3 months
To describe the S. aureus bacterial load (bacteriology) in the joint fluid up to 1 month
Time frame: From enrollment up to 1 month
To describe Cytology in the joint fluid
Time frame: From enrollment up to 1 month
To describe the hospitalization duration
Time frame: From enrollment up to 3 months and up to 12 months
To describe the hospitalization duration
Time frame: From enrollment up to 3 months and up to 12 months
To describe the quality of life for patients
Time frame: From enrollment up to 3 months and up to 12 months
To describe joint function rehabilitation
Time frame: From enrollment up to 3 months and up to 12 months
To describe the evolution of the prosthetic joint infection by X Ray image
Time frame: From screening up to 3 months and up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal Chief Medical Officer study director
Phagenix
Audrey Study Team Leader study director
Phagenix
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution and 0.9% NaCl solution in people with Hip Prosthesis Infection and Knee Prosthesis Infection, run by Phagenix.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal Chief Medical Officer (+33679732259, pascal.birman@phaxiam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of phage therapy + DAIR compared with placebo + DAIR (time frame: From enrollment up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.