Clinical trial NCT05369104: Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infection of Total Hip Joint Prosthesis
Infection of Total Knee Joint Prosthesis
Keywords: Joint Infection
Staphylococcus aureus
Phagotherapy
Lead sponsor: Phaxiam Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 18 years
2. 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)
3. 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
4. Without preoperative diagnosis of superinfection due to another pathogen
5. Phagogram displaying the susceptibility of the strain to at least one of the phages.
6. Patient with a life expectancy of 2 years and more as determined by the principal investigator
7. 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
8. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
9. Negative pregnancy test

Exclusion Criteria:

1. Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
2. Other germ found in culture of joint fluid sample
3. Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
4. Patients with ASA score ≥ 4
5. Severe sepsis or Septic shock or hemodynamic instability
6. Patients with an indication to prosthesis replacement or amputation
7. Immunosuppressed patients
8. ALT or AST \> 5 x ULN, creatinine \> 1.53 mg/dl in men and \> 1.24 mg/dl in women
9. Known allergic reactions to components of phages products
10. Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
11. 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
12. Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.

Primary outcomes:
measure: Clinical control of infection at week 12 visit
timeFrame: week 12 visit
Secondary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: From the time of signing the informed consent form up to study end visit (Months 24)
measure: Clinical laboratory tests
timeFrame: From the time of signing the informed consent form up to study end visit (Months 24)
measure: Physical examination
timeFrame: From the time of signing the informed consent form up to study end visit (Months 24)
measure: Clinical control of infection after Week 12 visit
timeFrame: Month 6, Month 12, Month 18 and Month 24.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pr Tristan Ferry
Study officials:
References: