Bacteriophage Therapy in Patients With Prosthetic Joint Infections

Adaptive Phage Therapeutics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Prosthetic Joint Infection

Treatments: Procedure: Two-Stage Exchange Arthroplasty; Biological: Phage Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04787250

APT.PJI.001

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm 1, Phage Therapy with Antibiotic Treatment

Experimental group

Description:

Phage therapy will be administered in conjunction with antibiotic treatment.

Treatment:

Biological: Phage Therapy

Arm 2, Standard of Care

Active Comparator group

Description:

Two-stage exchange arthroplasty entails resection arthroplasty and placement of an antibiotic-loaded spacer, antibiotic therapy, an antibiotic-free observation period, and re-implantation of a new prosthesis.

Treatment:

Procedure: Two-Stage Exchange Arthroplasty