Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.

NCT06605651 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: PP-SA-0032024-516555-40-00
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics. Standard treatment involves DAIR surgery and antibiotics, but there's a need for better solutions due to rising infections and antibiotic resistance. Bacteriophage therapy, which targets specific bacteria, shows promise. Phaxiam Therapeutics is studying the safety and efficacy of phage therapy in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.

Conditions

Hip Prosthesis Infection; Knee Prosthesis Infection

Keywords

Prosthetic Joint Infection; PJI; Bacteriophages; Phages; DAIR; Phage Therapy; Antimicrobials

Outcome Measures

Primary Outcomes (2)

• To assess the safety of phage therapy + DAIR compared with placebo + DAIR

  Incidence of serious adverse events

  From enrollment up to 3 months

• To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR

  Percentage of patients with clinical cure

  From enrollment up to 3 months

Secondary Outcomes (10)

• To assess the safety of phage therapy + DAIR compared with placebo + DAIR

  From enrollment up to 12 months

• To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR

  From enrollment up to 12 months

• To describe the immunological response in serum and in joint fluid

  From enrollment up to 3 months

• To describe the S. aureus bacterial load (bacteriology) in the joint fluid up to 1 month

  From enrollment up to 1 month

• To describe Cytology in the joint fluid

  From enrollment up to 1 month

Study Arms (2)

Active Arm

EXPERIMENTAL

Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution

Biological: Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution

Control Arm

PLACEBO COMPARATOR

0.9% NaCl solution

Drug: 0.9% NaCl solution

Interventions

Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution BIOLOGICAL

Three intra-articular injections during and/or following DAIR procedure

Active Arm

0.9% NaCl solution DRUG

Three intra-articular injections during and/or following DAIR procedure

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
• Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines
• Monobacterial Infection due to S. aureus
• Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered at the end of the DAIR (presence of a contaminant is not considered clinically relevant)
• Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed during the DAIR if treatment is administered up to 14 days after the DAIR
• Indication for Open DAIR decided by the Multidisciplinary Team and/or Principal Investigator
• Patient with a life expectancy of 1 year or 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 effective method of birth control until 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)

You may not qualify if:

• Relapse between DAIR and study drug administration planned up to 14 days after the DAIR.
• Patients who have two planned DAIR in sequence (double DAIR)
• Patients with ASA score ≥ 4
• Severe sepsis or Septic shock or hemodynamic instability
• Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation
• Indication for suppressive antibiotherapy
• 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)
• Positive Human Immunodeficiency Viruses (HIV) test or active hepatitis B and C
• Previous treatment by bacteriophages
• Any known phage allergy and/or to its excipients
• Elevated ALT or AST above 4 times ULN

Sponsors & Collaborators

• Phaxiam Therapeutics: lead

MeSH Terms

Interventions

Injections, Intra-Articular; Saline Solution

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pascal Chief Medical Officer

  Phaxiam Therapeutics

  STUDY DIRECTOR

• Audrey Study Team Leader

  Phaxiam Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Pascal Chief Medical Officer

CONTACT

+33679732259; pascal.birman@phaxiam.com

Audrey Study Team Leader

CONTACT

+33670637073; audrey.jacob@phaxiam.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study personnel (Investigator and their team, Sponsor's and CRO's Clinical Study Team will be blinded to subject treatment assignments except for the investigational pharmacist at each study site. The IWRS system will keep a coding list identifying the randomization number and the nature of the treatment allocated to each randomized patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an international, multicentric, phase II (proof of concept), randomized, double-blind, parallel group, placebo-controlled study.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 20, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share