Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

NCT05269121 — Phase 1 / Phase 2, Withdrawn, Adaptive Phage Therapeutics, Inc.

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An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection

Registry	NCT05269121, acronym ACTIVE1
Status	Withdrawn - Sponsor Decision
Phase	Phase 1 / Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Sponsor	Adaptive Phage Therapeutics, Inc. (Industry)
Conditions	Prosthetic Joint Infection, Bacterial Infections
Interventions	Phage Therapy (Biological)
Dates	start 2022-09-01 (estimated), primary completion 2023-11-01 (estimated), completion 2024-11-01 (estimated), first posted 2022-03-07, last updated 2024-02-22

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
DAIR + Phage Treatment + Antibiotics	Experimental	Biological: Phage Therapy	Phage therapy will be administered in conjunction with antibiotics.

Phage Therapy (Biological): Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators

Robert Hopkins, MD, Study chair, Adaptive Phage Therapeutics, Chief Medical Officer