Bacterial Infections, Prosthetic Joint Infection
Conditions
Keywords
Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR
Brief summary
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.
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 spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae. This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.
Interventions
BIOLOGICALPhage Therapy
Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.
Sponsors
Adaptive Phage Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females ≥18 years of age. * Stopped or not received SAT for 2 weeks * Female patients of childbearing potential who agree to use contraception. * First time chronic prosthetic joint infection * 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 * Unable to tolerate SAT * Septic shock or hemodynamic instability. * Chronic kidney disease * Liver disease * Decompensated heart failure. * Positive drug screen * Receiving chemotherapy * Immunocompromised * Antiviral treatment within 2 weeks prior to DAIR * Currently participating in another clinical trial * Known phage allergy * Pregnant/ breastfeeding * Lack of capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection | Day 1 through Week 24 | Incidence of reactions to study treatment and discontinuation due to adverse events |
| Treatment success | 13 months after DAIR | No recurrence or evidence of infection with the original pathogen at the same joint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No recurrence or evidence of infection for any reason | 3, 6, 13, or 24 months after DAIR | Infection due to the original or different pathogen at the index site |
Outcome results
None listed