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WITHDRAWNPhase 2NCT05269134

Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

Lead sponsor: Adaptive Phage Therapeutics, Inc.•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Adaptive Phage Therapeutics, Inc.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 30, 2023Terms

Trial snapshot

StatusWITHDRAWN

PhasePHASE2

Enrollment—

Start dateMar 2023

Last updatedNov 30, 2023

Condition

Prosthetic Joint Infection

Locations shown

University of California San Diego Medical Center

San Diego, California

Hartford Health Care Bone & Joint Insitute

Hartford, Connecticut

Snake River Research

Idaho Falls, Idaho

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2023Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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