Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.

Infection of Total Hip Joint Prosthesis Clinical Trial

— PhagoDAIRI  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369104
• Other study ID #: 2021-004469-11
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: June 16, 2025

Study information

• Verified date: June 2022
• Source: Pherecydes Pharma
• Contact: Alexandra TIZON
• Phone: +33184861613
• Email: alexandra.tizon[@]pherecydes-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 16, 2025
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection of Total Hip Joint Prosthesis
• Infection of Total Knee Joint Prosthesis
• Infections

Intervention

Biological:
• Anti-Staphylococcus aureus Bacteriophages
Single intra-articular injection

Locations

Country	Name	City	State
France	Pr Tristan Ferry	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Pherecydes Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 12 visit
Secondary	Adverse Events and Serious Adverse Events	Incidence, severity and type of adverse events and serious adverse events	From the time of signing the informed consent form up to study end visit (Months 24)
Secondary	Clinical laboratory tests	Number of participants with abnormal clinical laboratory tests	From the time of signing the informed consent form up to study end visit (Months 24)
Secondary	Physical examination	Number of participants with clinically abnormal physical examination findings	From the time of signing the informed consent form up to study end visit (Months 24)
Secondary	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	Month 6, Month 12, Month 18 and Month 24.