Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05269134

Acronym

ACTIVE2

Enrollment

Registered

2022-03-07

Start date

2023-03-27

Completion date

2027-07-31

Last updated

2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection

Keywords

Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR

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 at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae. This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.

Interventions

DRUGBacteriophage

Phage Therapy

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Double-Blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males or females ≥18 years of age * Recurrent PJI of the knee or hip * Female patients of childbearing potential who agree to use contraception. * 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 (other than PJI) requiring long term IV antibiotics * Unable to tolerate SAT * Septic shock or hemodynamic instability * Stage 4 or greater chronic kidney disease * Liver disease * Decompensated heart failure * Positive drug screen * Receiving chemotherapy * Immunocompromised * Treatment with antiviral medication within 2 weeks prior to randomization * Currently participating in another clinical trial * Known phage allergy * Pregnant/ breast feeding * Lack of capacity to consent

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI	Day 1 through Week 24	Incidence of reactions to study treatment and discontinuation due to adverse events
To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI	Day 1 through 24 months	Time to recurrence or evidence of infection with the original pathogen at the same joint

Secondary

Measure	Time frame	Description
Treatment success	Day 1 through 12 months	No recurrence or evidence of infection with the original pathogen at the same joint
No recurrence or evidence of infection for any reason	12 months after DAIR	Infection due to the original pathogen or a different pathogen

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026