Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

Bacterial Infections Clinical Trial

— ACTIVE1  

Official title:

An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05269121
• Other study ID #: APT.PJI.002
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Adaptive Phage Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bacterial Infections
• Communicable Diseases
• Infections
• Prosthetic Joint Infection

Intervention

Biological:
• Phage Therapy
Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adaptive Phage Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection	Incidence of reactions to study treatment and discontinuation due to adverse events	Day 1 through Week 24
Primary	Treatment success	No recurrence or evidence of infection with the original pathogen at the same joint	13 months after DAIR
Secondary	No recurrence or evidence of infection for any reason	Infection due to the original or different pathogen at the index site	3, 6, 13, or 24 months after DAIR