Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

Prosthetic Joint Infection Clinical Trial

— ACTIVE2  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05269134
• Other study ID #: APT.PJI.006
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 27, 2023
• Est. completion date: July 2027

Study information

• Verified date: October 2023
• Source: Adaptive Phage Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2027
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bacteriophage
Phage Therapy
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	New England Baptist Hospital	Boston	Massachusetts
United States	Hartford Health Care Bone & Joint Insitute	Hartford	Connecticut
United States	Snake River Research	Idaho Falls	Idaho
United States	WVU Medicine JW Ruby Memorial Hospital	Morgantown	West Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of California San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Adaptive Phage Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI	Incidence of reactions to study treatment and discontinuation due to adverse events	Day 1 through Week 24
Primary	To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI	Time to recurrence or evidence of infection with the original pathogen at the same joint	Day 1 through 24 months
Secondary	Treatment success	No recurrence or evidence of infection with the original pathogen at the same joint	Day 1 through 12 months
Secondary	No recurrence or evidence of infection for any reason	Infection due to the original pathogen or a different pathogen	12 months after DAIR