Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

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 at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae. This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Prosthetic Joint Infection

Interventions

BacteriophageDRUG

Phage Therapy

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females ≥18 years of age * Recurrent PJI of the knee or hip * Female patients of childbearing potential who agree to use contraception. * Confirmed phage match * No anticipated need for long-term antibiotics Exclusion Criteria: * Soft tissue defect requiring reconstruction * Hardware misalignment * Additional orthopedic hardware in connection with the infected prosthesis * Active infection (other than PJI) requiring long term IV antibiotics * Unable to tolerate SAT * Septic shock or hemodynamic instability * Stage 4 or greater chronic kidney disease * Liver disease * Decompensated heart failure * Positive drug screen * Receiving chemotherapy * Immunocompromised * Treatment with antiviral medication within 2 weeks prior to randomization * Currently participating in another clinical trial * Known phage allergy * Pregnant/ breast feeding * Lack of capacity to consent

Locations (10)

University of California San Diego Medical Center

San Diego, California, United States

Hartford Health Care Bone & Joint Insitute

Hartford, Connecticut, United States

Snake River Research

Idaho Falls, Idaho, United States

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI

Incidence of reactions to study treatment and discontinuation due to adverse events

Time frame: Day 1 through Week 24

To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI

Time to recurrence or evidence of infection with the original pathogen at the same joint

Time frame: Day 1 through 24 months

Secondary Outcomes

Treatment success

No recurrence or evidence of infection with the original pathogen at the same joint

Time frame: Day 1 through 12 months

No recurrence or evidence of infection for any reason

Infection due to the original pathogen or a different pathogen

Time frame: 12 months after DAIR

Data from ClinicalTrials.gov

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