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Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05177107
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
Adaptive Phage Therapeutics, Inc.

Study Description
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Brief Summary:
This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis.

Condition or disease Intervention/treatment Phase
Osteomyelitis Diabetic Foot Osteomyelitis Biological: Phage Therapy Other: Placebo Phase 2

Detailed Description:
This study will evaluate the safety and efficacy of bacteriophage therapy in patients with diabetic foot osteomyelitis (DFO). Enrolled patients will have osteomyelitis infections due to Staph aureus. This study will include eligible patients who have undergone or are planning to undergo surgical debridement of DFO.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:1, phage: placebo
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Double-blind:

Patient will be randomized to receive either active phage or placebo treatment.
Primary Purpose: Treatment
Official Title: A Phase IIa Randomized, Parallel Group, Double-blind, Repeat Dose, Investigating the Safety, Tolerability, and Efficacy of Phage Treatment and Standard of Care Antimicrobials for Patients With Diabetic Foot Osteomyelitis
Actual Study Start Date : November 24, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: Phage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
 Biological: Phage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Placebo Comparator: Group 2: Placebo
Placebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy).
 Other: Placebo
Placebo (normal saline)


Outcome Measures
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Primary Outcome Measures :
  1. Percent area reduction of study ulcer through Week 13 [ Time Frame: Baseline through Week 13 ]
    Percent area reduction of the study ulcer surface area from baseline through Week 13


Secondary Outcome Measures :
  1. Complete healing of the study ulcer [ Time Frame: Baseline through Week 13 ]
    Time to complete healing of the ulcer at any time point during the study

  2. Time to 85% reduction of C-reactive protein (CRP) [ Time Frame: Baseline through Week 13 ]
    Time to 85% reduction of CRP at any time point during the study

  3. Microbiological eradication of the target pathogen [ Time Frame: baseline through Week 13 ]
    Percentage of patients with microbiological eradication of the target pathogen at each time point during the study.


Other Outcome Measures:
  1. Treatment-emergent AEs due to phage therapy [ Time Frame: baseline through Week 12 ]
    Number and percent of treatment-emergent Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥18 to <85 years of age.
  • Ongoing diagnosis of diabetes.
  • Have undergone or are scheduled to undergo surgical debridement for DFO as part of Standard of Care, with the associated bone culture positive for S. aureus and with the associated histology results consistent with the diagnosis of DFO.
  • Meet defined study ulcer requirements as defined in the protocol

Exclusion Criteria:

  • Healing of the ulcer by more than 30% between screening and randomization.
  • Evidence of sinus tract.
  • Suspicion of neoplasm associated with the study ulcer or any non-study diabetic ulcer independent of biopsy result.
  • Presence of erythema ≥4 cm at the study ulcer site.
  • Presence of any cellulitis not localized to the study ulcer.
  • Indwelling hardware at the site of the DFO.
  • Body mass index of >40 or weight <50 kg.
  • Presence of leg ulcer(s), regardless of limb.
  • Abnormal liver function tests
  • HbA1c value of more than 12%
  • Any other clinically significant or severe disease that in the judgment of the investigator makes the patient unfit for the study or likely to withdraw prematurely from the study, or that could jeopardize the safety of the patient or confound the results of the study.
  • Known allergy to phage products.
  • Pregnant and/or breastfeeding.
  • Immunocompromised at screening in the judgment of the investigator.
  • Taking any systemic or topical antibacterial antibiotic within 2 weeks prior to the start of study treatment, for a condition other than Diabetic Foot Infection and DFO.
  • Taking any antiviral medication within 2 weeks prior to the start of study treatment and up through the last administration of study treatment.
  • Taking and/or receiving any therapies for the study ulcer that are not considered to be SOC.
  • Participating in another clinical trial within 4 weeks prior to screening.
  • Inability to obtain or provide informed consent or adhere to the protocol in the judgment of the investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05177107


Contacts
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Contact: Stephanie Holland 202-391-8058 sholland@aphage.com

Locations
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United States, Arizona
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Phyllis Houston    520-792-1450 ext 14548    phyllis.houston@va.gov   
Principal Investigator: Jodi Walters         
United States, Arkansas
Central Arkansas Veteran's Healthcare System Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Sandra Brock    501-257-6906    brocksandraj@uams.edu   
Principal Investigator: Mohammed Moursi, MD         
United States, Colorado
Rocky Mountain VA Recruiting
Aurora, Colorado, United States, 80045
Contact: Anna Wyrwa    720-409-6402      
Principal Investigator: Lindsay Nicholson         
United States, Florida
University of Florida Health - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Marie Jimenez    904-244-8269    marie.jimenez@jax.ufl.edu   
Principal Investigator: Jason Piraino, DPM         
Floridian Clinical Research Recruiting
Miami Lakes, Florida, United States, 33016
Contact: Ivan Garcia       igarcia@floridiancr.com   
Principal Investigator: Gregorio Caban, DPM         
LCC Medical Research Recruiting
Miami, Florida, United States, 33126
Contact: Johana Alvarez    305-400-0814      
Principal Investigator: Jacob Silverstone         
Infectious Disease Consultants od the Treasure Coast Recruiting
Sebastian, Florida, United States, 32958
Contact: Natalie Van Cleave         
Principal Investigator: Laurie Welton         
United States, Idaho
Advanced Specialty Research Recruiting
Boise, Idaho, United States, 83702
Contact: Margaret Tracey    208-906-1600    margaret@idahoasr.com   
Principal Investigator: Philip Burk         
United States, New Jersey
Jersey Shore University Medical Center Not yet recruiting
Neptune, New Jersey, United States, 07753
Contact: Erin Anderson    732-776-3312    erin.anderson@hmhn.org   
Principal Investigator: Edward Liu         
CurAlta Foot and Ankle Recruiting
Westwood, New Jersey, United States, 07675
Contact: Vincent Giacalone         
Principal Investigator: Vincent Giacalone         
United States, New York
James J. Peters VA Recruiting
Bronx, New York, United States, 10468
Contact: Olga Andriunas    718-584-9000 ext 6671    olga.andriunas@va.gov   
Principal Investigator: Michael Gelman         
United States, Oklahoma
Nextstage Tulsa Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Nga Vo    918-720-8271    nvo@nextstageclinical.com   
Sub-Investigator: Darnell Blackmon         
United States, Pennsylvania
Martin Foot and Ankle Withdrawn
York, Pennsylvania, United States, 17402
United States, Texas
Futuro Clinical Trials, LLC Recruiting
McAllen, Texas, United States, 78501
Contact: Chrissy Rodriguez    956-999-8399    chrissycffc@gmail.com   
Principal Investigator: Joseph Caporusso, DPM         
United States, Virginia
Salem VA Recruiting
Salem, Virginia, United States, 24153
Contact: Tracey Ochalek    540-892-2463      
Principal Investigator: Shikha Vasudeva         
Sponsors and Collaborators
Adaptive Phage Therapeutics, Inc.
Investigators
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Principal Investigator: Edward Fang Chief Medical Officer
More Information
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Additional Information:

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Responsible Party: Adaptive Phage Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05177107    
Other Study ID Numbers: APT.DFI.001
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaptive Phage Therapeutics, Inc.:
Diabetes
Osteomyelitis
Foot Infection
Phage Treatment
 Bacteriophage
Phage
Bone Infection
Additional relevant MeSH terms:
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Osteomyelitis
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases