Clinical trial NCT04787250: Bacteriophage Therapy in Patients With Prosthetic Joint Infections
Official title: Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Prosthetic Joint Infection
Keywords: Prosthetic
Joint
Knee
Hip
Phage
Bacteriophage
Prosthetic Joint
Lead sponsor: Adaptive Phage Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2021-03-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, open-label, parallel-group design
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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.

This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.

Eligibility criteria: General Inclusion Criteria:

* Males or females ≥18 years of age.
* Female patients of childbearing potential who agree to use contraception.
* Candidate for a two-stage exchange arthroplasty.
* Chronic prosthetic joint infection

General Exclusion Criteria:

* Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure
* Soft tissue defect requiring reconstruction
* Hardware misalignment or loosening
* Active osteomyelitis
* Septic shock or hemodynamic instability
* Stage 4 or greater chronic kidney disease
* Liver disease
* Decompensated cirrhosis
* Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis
* Decompensated heart failure
* Any other clinically significant disease, per judgement of the investigator
* Neutropenia (neutrophil count \< 1000 cells/cubic mm), thrombocytopenia (platelets \< 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 3 time the upper limit of normal
* HIV, hepatitis C, hepatitis B infection
* Positive drug screen
* Receipt of chemotherapy, immunosuppressants or immune modulators
* Anti-viral medication
* Any known phage allergy
* Breast feeding or pregnancy

Primary outcomes:
measure: Safety and tolerability of phage therapy
timeFrame: Day 1 through Week 26
Secondary outcomes:
measure: Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.
timeFrame: 6 weeks after completion of phage therapy
measure: Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
timeFrame: Week 26
measure: Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).
timeFrame: Week 26
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Adaptive Phage Therapeutics
name: Robert J Hopkins, MD
role: STUDY_DIRECTOR
References: