Bacteriophage Therapy in Patients With Prosthetic Joint Infections

Adaptive Phage Therapeutics, Inc.

Overview

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae. This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Prosthetic Joint Infection

Interventions

Phage TherapyBIOLOGICAL

Phage will be administered based on patient's matching results.

Two-Stage Exchange ArthroplastyPROCEDURE

Performed per the study center's standard of care. No investigational products are used.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

General Inclusion Criteria: * Males or females ≥18 years of age. * Female patients of childbearing potential who agree to use contraception. * Candidate for a two-stage exchange arthroplasty. * Chronic prosthetic joint infection General Exclusion Criteria: * Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure * Soft tissue defect requiring reconstruction * Hardware misalignment or loosening * Active osteomyelitis * Septic shock or hemodynamic instability * Stage 4 or greater chronic kidney disease * Liver disease * Decompensated cirrhosis * Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis * Decompensated heart failure * Any other clinically significant disease, per judgement of the investigator * Neutropenia (neutrophil count \< 1000 cells/cubic mm), thrombocytopenia (platelets \< 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 3 time the upper limit of normal * HIV, hepatitis C, hepatitis B infection * Positive drug screen * Receipt of chemotherapy, immunosuppressants or immune modulators * Anti-viral medication * Any known phage allergy * Breast feeding or pregnancy

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Safety and tolerability of phage therapy

Incidence and type of adverse events and infusion reactions

Time frame: Day 1 through Week 26

Secondary Outcomes

Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.

Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection.

Time frame: 6 weeks after completion of phage therapy

Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).

Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score.

Time frame: Week 26

Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).

Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.

Time frame: Week 26

Data from ClinicalTrials.gov

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