Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections (ACTIVE1)

February 21, 2024 updated by: Adaptive Phage Therapeutics, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DAIR + Phage Treatment + Antibiotics
Phage therapy will be administered in conjunction with antibiotics.
Biological: Phage Therapy
Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
Time Frame: Day 1 through Week 24
Incidence of reactions to study treatment and discontinuation due to adverse events
Day 1 through Week 24
Treatment success
Time Frame: 13 months after DAIR
No recurrence or evidence of infection with the original pathogen at the same joint
13 months after DAIR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No recurrence or evidence of infection for any reason
Time Frame: 3, 6, 13, or 24 months after DAIR
Infection due to the original or different pathogen at the index site
3, 6, 13, or 24 months after DAIR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adaptive Phage Therapeutics, Inc.

Investigators

  • Study Chair: Robert Hopkins, MD, Adaptive Phage Therapeutics, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APT.PJI.002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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