Infection of Total Hip Joint ProsthesisPhase 2PhagoDAIRINCT05369104
Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
A Phase 2 study testing Anti-Staphylococcus aureus Bacteriophages in people with Infection of Total Hip Joint Prosthesis and Infection of Total Knee Joint Prosthesis, run by Phagenix at 1 site in France.
Trial summary
Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection of Total Hip Joint Prosthesis, Infection of Total Knee Joint Prosthesis
- What is being tested?
- Anti-Staphylococcus aureus Bacteriophages
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2022to 16 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Staphylococcus aureus monomicrobial knee or hip PJI ˃3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT)
- Staphylococcus aureus only in joint fluid within 6 months before randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months before pre-inclusion visit
- Without preoperative diagnosis of superinfection due to another pathogen
- Phagogram displaying the susceptibility of the strain to at least one of the phages.
- Patient with a life expectancy of 2 years and more as determined by the principal investigator
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- Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 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)
- Negative pregnancy test
Who cannot join
- Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
- Other germ found in culture of joint fluid sample
- Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
- Patients with ASA score ≥ 4
- Severe sepsis or Septic shock or hemodynamic instability
- Patients with an indication to prosthesis replacement or amputation
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- Immunosuppressed patients
- ALT or AST > 5 x ULN, creatinine > 1.53 mg/dl in men and > 1.24 mg/dl in women
- Known allergic reactions to components of phages products
- Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
- Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug
- Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Multicenter, Randomized, Non-Comparative, Double-Blind Study of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR and Antibiotic Therapy.
Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT.
- Being tested
- Anti-Staphylococcus aureus Bacteriophages
- Keywords
- Joint Infection, Staphylococcus aureus, Phagotherapy
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Staphylococcus aureus BacteriophagesBiological
Single intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Bacteriophages arm | Experimental | 1 mL (PP1493 or PP1815) or 2 mL (PP1493 and PP1815) of suspension of bacteriophages diluted in solution of NaCl 0,9% at the end of DAIR procedure. Receives: Biological: Anti-Staphylococcus aureus Bacteriophages |
| Control Arm | Placebo comparator | One local administration of NaCl 0,9% solution is administered at the end of the DAIR procedure. Receives: Biological: Anti-Staphylococcus aureus Bacteriophages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical control of infection at week 12 visit
No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid.
Measured: week 12 visit
Secondary outcomes (4)
Adverse Events and Serious Adverse Events
Incidence, severity and type of adverse events and serious adverse events
Measured: From the time of signing the informed consent form up to study end visit (Months 24)
Clinical laboratory tests
Number of participants with abnormal clinical laboratory tests
Measured: From the time of signing the informed consent form up to study end visit (Months 24)
Physical examination
Number of participants with clinically abnormal physical examination findings
Measured: From the time of signing the informed consent form up to study end visit (Months 24)
Clinical control of infection after Week 12 visit
No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid
Measured: Month 6, Month 12, Month 18 and Month 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start15 Jun 2022
- Primary completion16 Dec 2023 (estimated)
- Study completion16 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection of Total Hip Joint ProsthesisStudies 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 a pilot, randomized, non-comparative, double-blind study in patients with knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication of DAIR and Suppressive Antibiotics Therapy (SAT). A stratification will be performed on the affected area of arthroplasty: knee or hip and on study site.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phagenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369104
- Sponsor's protocol ID
- 2021-004469-11
- Acronym
- PhagoDAIRI
- Status last verified
- Jun 2022
- First submitted
- 27 Apr 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferry T. A Review of Phage Therapy for Bone and Joint Infections. Methods Mol Biol. 2024;2734:207-235. doi: 10.1007/978-1-0716-3523-0_14.
PubMed 38066372
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Multicenter, Randomized, Non-Comparative, Double-Blind Study of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR and Antibiotic Therapy.
- ClinicalTrials.gov ID
- NCT05369104
- Acronym / sponsor ID
- PhagoDAIRI / 2021-004469-11
- Keywords
- Joint Infection, Staphylococcus aureus, Phagotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- PhagenixIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 16 Dec 2023 (estimated)
- Study completion
- 16 Jun 2025 (estimated)
- First posted
- 11 May 2022 (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.
Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a pilot, randomized, non-comparative, double-blind study in patients with knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication of DAIR and Suppressive Antibiotics Therapy (SAT). A stratification will be performed on the affected area of arthroplasty: knee or hip and on study site.
| Arm | Type | Receives |
|---|---|---|
| Bacteriophages arm | Experimental | Biological: Anti-Staphylococcus aureus Bacteriophages1 mL (PP1493 or PP1815) or 2 mL (PP1493 and PP1815) of suspension of bacteriophages diluted in solution of NaCl 0,9% at the end of DAIR procedure. |
| Control Arm | Placebo comparator | Biological: Anti-Staphylococcus aureus BacteriophagesOne local administration of NaCl 0,9% solution is administered at the end of the DAIR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 18 years
- Staphylococcus aureus monomicrobial knee or hip PJI ˃3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT)
- Staphylococcus aureus only in joint fluid within 6 months before randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months before pre-inclusion visit
- Without preoperative diagnosis of superinfection due to another pathogen
- Phagogram displaying the susceptibility of the strain to at least one of the phages.
Key exclusion criteria (12 listed)
- Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
- Other germ found in culture of joint fluid sample
- Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
- Patients with ASA score ≥ 4
- Severe sepsis or Septic shock or hemodynamic instability
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 BacteriophagesSingle intra-articular injection | Biological | Bacteriophages arm, Control Arm |
Primary outcome
Clinical control of infection at week 12 visit
Time frame: week 12 visit
No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid.
4 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: From the time of signing the informed consent form up to study end visit (Months 24)
Clinical laboratory tests
Time frame: From the time of signing the informed consent form up to study end visit (Months 24)
Physical examination
Time frame: From the time of signing the informed consent form up to study end visit (Months 24)
Clinical control of infection after Week 12 visit
Time frame: Month 6, Month 12, Month 18 and Month 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 38066372Ferry T. A Review of Phage Therapy for Bone and Joint Infections. Methods Mol Biol. 2024;2734:207-235. doi: 10.1007/978-1-0716-3523-0_14.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-Staphylococcus aureus Bacteriophages in people with Infection of Total Hip Joint Prosthesis and Infection of Total Knee Joint Prosthesis, run by Phagenix at 1 site in France.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra TIZON (+33184861613, alexandra.tizon@pherecydes-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical control of infection at week 12 visit (time frame: week 12 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369104, which also lists 1 linked publication.
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 22 Jun 2022.