PP1493 for Prosthetic joint infection (hip or knee) due to Staphylococcus aureus

Inclusion criteria

• {"criterion_text":"- Male or female ≥ 18 years\n- Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)\n- Negative pregnancy test for women of childbearing potential\n- Signing a written informed consent before any study related procedures including [redacted]\n- Affiliated to a national social security system and / or private health insurance in compliance with the recommendations of National Law in force relating to biomedical research.\n- Knee or Hip PJI according to EBJIS or ICM guidelines (Appendix 6 of protocol)\n- Monobacterial Infection due to S. aureus\n- Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered [redacted] the DAIR (presence of a contaminant is not considered clinically relevant)\n- Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed [redacted] DAIR if treatment is administered [redacted] the DAIR\n- Indication for Open DAIR decided by the Multidisciplinary Team and/or Principal Investigator\n- S. aureus in [redacted] during the pre-inclusion period or in case of relapse of infection under antibiotics therapy in the last 6 months before inclusion\n- Patient with a life expectancy of 1 year and more as determined by the principal investigator.\n- 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. These include, but not limited to: a.Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, or transdermal), b.Progestogen-only hormonal contraception (oral, injectable, or implantable), c.Intrauterine device, Intrauterine hormone-releasing system, d.Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. e.For non-vasectomized men having a female partner of childbearing potential, men must agree to use condom until 30 days after the last administration of the study drug."}

Exclusion criteria

• {"criterion_text":"- Relapse between DAIR and study drug administration [redacted].\n- Any known phage allergy and/or to its excipients\n- Elevated ALT or AST above 4 times ULN\n- Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study.\n- Patient who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.\n- Currently in exclusion period from a previous study\n- Participate or plan to receive any other investigational drug or therapy or vaccine during the study period.\n- Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period or 1 month after the last administration of study drug.\n- Women/Men refusing to use an acceptable effective contraception until 1 month after the last administration of study drug.\n- Minors, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care and persons admitted to a health or social institution, to adult patient under legal protection or unable to express consent.\n- Patients who have two planned DAIR in sequence (double DAIR)\n- Patients with ASA score ≥ 4\n- Severe sepsis or Septic shock or hemodynamic instability\n- Patients with an indication for prosthesis exchange, or for joint fusion or for amputation\n- Indication for suppressive antibiotherapy\n- 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)\n- Positive HIV test or active hepatitis B and C\n- Previous treatment by bacteriophages"}

Primary endpoints

• {"endpoint_text":"- Incidence of serious adverse events up to 3 months","definition_or_measurement_approach":"Incidence of serious adverse events measured up to 3 months (timeframe specified in endpoint)."}
• {"endpoint_text":"- Percentage of Patients with clinical cure up to 3 months","definition_or_measurement_approach":"Percentage of patients achieving clinical cure assessed up to 3 months (timeframe specified in endpoint)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with clinical cure from S.aureus infection up to 3 months and 12 months. Percentage of patients with relapse exclusively due to another germ than Staphylococcus aureus up to 3 month and 12 months","definition_or_measurement_approach":"Clinical cure from S. aureus infection and relapse due to other pathogens measured at up to 3 months and 12 months."}
• {"endpoint_text":"- Incidence of all adverse events and assessment of all safety parameters (Vital signs, ECG/ Echocardiography, hematology, hemostasis and biochemistry) up to 3 months and up to 12 months","definition_or_measurement_approach":"All adverse events and specified safety parameters monitored and assessed up to 3 months and up to 12 months."}
• {"endpoint_text":"- Percentage of Patient with clinical cure of PJI and up to 12 months.","definition_or_measurement_approach":"Percentage of patients with clinical cure of prosthetic joint infection assessed up to 12 months."}
• {"endpoint_text":"- Titration of anti-S. aureus phage antibodies: -In [redacted] at [redacted] in case of relapse and at Early End Visit if it’s occurred before [redacted] for all patients. -In [redacted] at [redacted] in case of relapse if it’s occurred before [redacted] (all patient) and only for knee PJI patients at [redacted].","definition_or_measurement_approach":"Titration of anti-S. aureus phage antibodies at specified visits and timepoints (details redacted); measured in relapse and early end-visit conditions as specified."}
• {"endpoint_text":"- Quantitative or Semi-Quantitative Analysis of bacterial load at [redacted] (all patient) and only for knee PJI patient at [redacted].","definition_or_measurement_approach":"Quantitative or semi-quantitative bacterial load measurements at specified timepoints (details redacted)."}
• {"endpoint_text":"- Quantification and identification of polynuclear of [redacted] at [redacted] (all patients) and [redacted] (only knee PJI).","definition_or_measurement_approach":"Quantification and identification of polynuclear cells at specified samples/timepoints (details redacted)."}
• {"endpoint_text":"- Number and Duration of hospitalization up to 3 months and up to 12 months","definition_or_measurement_approach":"Number and duration of hospitalizations tracked and summarized for up to 3 months and up to 12 months."}
• {"endpoint_text":"- Quality-of-life questionnaires [redacted] at [redacted].","definition_or_measurement_approach":"Quality-of-life assessed using specified questionnaires at specified visits/timepoints (details redacted)."}
• {"endpoint_text":"- [redacted] Questionnaires at [redacted].","definition_or_measurement_approach":"Additional questionnaires administered at specified visits/timepoints (details redacted)."}
• {"endpoint_text":"- X Ray during [redacted] period and at [redacted] to check potential appearance of abnormal loosening (border with shifting of the prosthesis), periprosthetic border.","definition_or_measurement_approach":"Radiographic assessment (X-ray) at specified periods to evaluate for abnormal prosthesis loosening and periprosthetic changes."}

France

Earliest CTIS Part Ii Submission Date

25-02-2025

Latest Decision Or Authorization Date

24-03-2025

Processing Time Days

27

Number Of Sites

7

Number Of Participants

32

Spain

Earliest CTIS Part Ii Submission Date

14-03-2025

Latest Decision Or Authorization Date

18-03-2025

Processing Time Days

4

Number Of Sites

2

Number Of Participants

9

Netherlands

Earliest CTIS Part Ii Submission Date

11-03-2025

Latest Decision Or Authorization Date

18-03-2025

Processing Time Days

7

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Phaxiam Therapeutics

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

RCTS Randomized Clinical Trials

Responsibilities

['1','10','11','2','3','5','6','7']

Third parties

• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"['4']","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"France","full_name":"RCTS Randomized Clinical Trials","duties_or_roles":"['1','10','11','2','3','5','6','7']","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"['14']","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"['8']","organisation_type":"Pharmaceutical company"}