Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections (ACTIVE1)

Adaptive Phage Therapeutics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Prosthetic Joint Infection; Bacterial Infections

Treatments: Biological: Phage Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05269121

APT.PJI.002

Details and patient eligibility

About

This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.

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 spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.

This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females ≥18 years of age.
• Stopped or not received SAT for 2 weeks
• Female patients of childbearing potential who agree to use contraception.
• First time chronic prosthetic joint infection
• 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
• Unable to tolerate SAT
• Septic shock or hemodynamic instability.
• Chronic kidney disease
• Liver disease
• Decompensated heart failure.
• Positive drug screen
• Receiving chemotherapy
• Immunocompromised
• Antiviral treatment within 2 weeks prior to DAIR
• Currently participating in another clinical trial
• Known phage allergy
• Pregnant/ breastfeeding
• Lack of capacity to consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

DAIR + Phage Treatment + Antibiotics

Experimental group

Description:

Phage therapy will be administered in conjunction with antibiotics.

Treatment:

Biological: Phage Therapy