ACTIVE1: Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

• Sponsor: Adaptive Phage Therapeutics, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05269121
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 30.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prosthetic Joint Infection; Bacterial Infections	Biological: Phage Therapy	Phase 1/Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAIR + Phage Treatment + Antibiotics Phage therapy will be administered in conjunction with antibiotics.	Biological: Phage Therapy; Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

Outcome Measures

Primary Outcome Measures

1. To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection [Day 1 through Week 24]

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

2. Treatment success [13 months after DAIR]

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

Secondary Outcome Measures

1. No recurrence or evidence of infection for any reason [3, 6, 13, or 24 months after DAIR]

   Infection due to the original or different pathogen at the index site

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Adaptive Phage Therapeutics, Inc.

Investigators

• Study Chair: Robert Hopkins, MD, Adaptive Phage Therapeutics, Chief Medical Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adaptive Phage Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05269121
• Other Study ID Numbers: APT.PJI.002
• First Posted: Mar 7, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Adaptive Phage Therapeutics, Inc.: Prosthetic; Joint; Knee; Hip; Phage; Bacteriophage; Prosthetic Joint; DAIR
• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Arthritis, Infectious

Study Results

No Results Posted as of Mar 22, 2022