Clinical trial NCT05269134: Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prosthetic Joint Infection
Keywords: Prosthetic
Joint
Knee
Hip
Phage
Bacteriophage
Prosthetic Joint
DAIR
Lead sponsor: Adaptive Phage Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
timeFrame: Day 1 through Week 24
measure: To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
timeFrame: Day 1 through 24 months
Secondary outcomes:
measure: Treatment success
timeFrame: Day 1 through 12 months
measure: No recurrence or evidence of infection for any reason
timeFrame: 12 months after DAIR
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Health Care Bone & Joint Insitute
state: Connecticut
city: Idaho Falls
country: United States
facility: Snake River Research
state: Idaho
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morgantown
country: United States
facility: WVU Medicine JW Ruby Memorial Hospital
state: West Virginia
Study officials:
affiliation: Adaptive Phage Therapeutics, Chief Medical Officer
name: Edward Fang, MD
role: STUDY_CHAIR
References: