Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05269134
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Adaptive Phage Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Edward Fang, MD
Principal Investigator Affiliation Adaptive Phage Therapeutics, Chief Medical Officer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Prosthetic Joint Infection
Additional Details

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.

Arms & Interventions

Arms

Experimental: DAIR + Phage Treatment + Antibiotics

Phage therapy will be administered in conjunction with antibiotic treatment.

Placebo Comparator: DAIR + Placebo + Antibiotics

Placebo will be administered in conjunction with antibiotic treatment.

Interventions

Drug: - Bacteriophage

Phage Therapy

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hartford, Connecticut

Status

Recruiting

Address

Hartford Health Care Bone & Joint Insitute

Hartford, Connecticut, 06106

Site Contact

Jake Corsa

[email protected]

(606) 992-0589

Snake River Research, Idaho Falls, Idaho

Status

Recruiting

Address

Snake River Research

Idaho Falls, Idaho, 83404

Site Contact

Jennifer Morrison

[email protected]

(606) 992-0589

University of Maryland Medical Center, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland Medical Center

Baltimore, Maryland, 21201

Site Contact

Lisa Anderson

[email protected]

(606) 992-0589

Sinai Hospital of Baltimore, Baltimore, Maryland

Status

Recruiting

Address

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Site Contact

Raj Shrestha

[email protected]

(606) 992-0589

Brigham & Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham & Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Joshua Davis

[email protected]

(606) 992-0589

New England Baptist Hospital, Boston, Massachusetts

Status

Recruiting

Address

New England Baptist Hospital

Boston, Massachusetts, 02120

Site Contact

Sade Olatunbosun

[email protected]

(606) 992-0589

William Beaumont Hospital, Royal Oak, Michigan

Status

Recruiting

Address

William Beaumont Hospital

Royal Oak, Michigan, 48073

Site Contact

Tori Ozark

[email protected]

(606) 992-0589

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Jacob Bjerke

[email protected]

(606) 992-0589

WVU Medicine JW Ruby Memorial Hospital, Morgantown, West Virginia

Status

Recruiting

Address

WVU Medicine JW Ruby Memorial Hospital

Morgantown, West Virginia, 26506

Site Contact

Jennifer Eicher

[email protected]

(606) 992-0589