A Phase 1/2 interventional study of Phage Therapy and Two-Stage Exchange Arthroplasty in Prosthetic Joint Infection, sponsored by Adaptive Phage Therapeutics, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Adaptive Phage Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
Browse Infections studies →Adaptive Phage Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria:
General Exclusion Criteria:
Phage therapy will be administered in conjunction with antibiotic treatment.
Biological: Phage Therapy
Two-stage exchange arthroplasty entails resection arthroplasty and placement of an antibiotic-loaded spacer, antibiotic therapy, an antibiotic-free observation period, and re-implantation of a new prosthesis.
Procedure: Two-Stage Exchange Arthroplasty
Phage will be administered based on patient's matching results.
Also known as: Antibiotics
Performed per the study center's standard of care. No investigational products are used.
Also known as: Antibiotics
Safety and tolerability of phage therapy
Incidence and type of adverse events and infusion reactions
Time frame: Day 1 through Week 26
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.
Time frame: 6 weeks after completion of phage therapy
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.
Time frame: Week 26
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.
Time frame: Week 26
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Adaptive Phage Therapeutics, Inc.