Bacteriophage Therapy in Patients With Prosthetic Joint Infections

Prosthetic Joint Infection Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04787250
• Other study ID #: APT.PJI.001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: October 2022
• Est. completion date: May 2024

Study information

• Verified date: March 2022
• 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 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.

Recruitment information / eligibility

• Status: Withdrawn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

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Phage Therapy
Phage will be administered based on patient's matching results.

Procedure:
• Two-Stage Exchange Arthroplasty
Performed per the study center's standard of care. No investigational products are used.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Adaptive Phage Therapeutics, Inc.	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of phage therapy	Incidence and type of adverse events and infusion reactions	Day 1 through Week 26
Secondary	Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.	Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection.	6 weeks after completion of phage therapy
Secondary	Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).	Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score.	Week 26
Secondary	Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).	Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.	Week 26