Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI) (ACTIVE2)

Adaptive Phage Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Prosthetic Joint Infection

Treatments: Drug: Placebo; Drug: Bacteriophage

Study type: Interventional

Funder types: Industry

Identifiers

NCT05269134

APT.PJI.006

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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

DAIR + Phage Treatment + Antibiotics

Experimental group

Description:

Phage therapy will be administered in conjunction with antibiotic treatment.

Treatment:

Drug: Bacteriophage

DAIR + Placebo + Antibiotics

Placebo Comparator group

Description:

Placebo will be administered in conjunction with antibiotic treatment.

Treatment:

Drug: Placebo