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

NCT05369104 | Unknown Phase 2

• 1 other identifier: 2021-004469-11
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection of Total Hip Joint Prosthesis; Infection of Total Knee Joint Prosthesis

Keywords

Joint Infection; Staphylococcus aureus; Phagotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adverse Events and Serious Adverse Events

  From the time of signing the informed consent form up to study end visit (Months 24)

• Clinical laboratory tests

  From the time of signing the informed consent form up to study end visit (Months 24)

• Physical examination

  From the time of signing the informed consent form up to study end visit (Months 24)

• Clinical control of infection after Week 12 visit

  Month 6, Month 12, Month 18 and Month 24.

Study Arms (2)

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.

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.

Biological: Anti-Staphylococcus aureus Bacteriophages

Interventions

Anti-Staphylococcus aureus Bacteriophages BIOLOGICAL

Single intra-articular injection

Bacteriophages arm; Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Phaxiam Therapeutics: lead

Study Sites (1)

Pr Tristan Ferry

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Alexandra TIZON

CONTACT

+33184861613; alexandra.tizon@pherecydes-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All persons will be blinded, except the pharmacist will be unmasking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 11, 2022
• Study Start: June 15, 2022
• Primary Completion: December 16, 2023
• Study Completion: June 16, 2025
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)