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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05177107
Other study ID # APT.DFI.001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 24, 2021
Est. completion date December 2024

Study information

Verified date September 2023
Source Adaptive Phage Therapeutics, Inc.
Contact Staci Steele
Phone 844-972-0500
Email ssteele@aphage.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date December 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 SoC, with the associated bone culture positive for S. aureus - Availability of at least 1 matching phage for S. aureus cultured from the bone culture - Receiving SoC treatment for DFO, including antibiotics after debridement and before randomization - Meet defined study ulcer requirements as defined in the protocol - Adequate circulation to the affected extremity demonstrated within 3 months prior to randomization and no revascularization procedure anticipated - History of compliance with prior appointments and treatments in the investigator's opinion and willingness to receive and comply with SOC antimicrobial and clinical treatments for the study ulcer, including offloading Exclusion Criteria: - Healing of the ulcer by more than 30% between screening and randomization. - Treated with hyperbaric oxygen or cellular/tissue products with 30 days of screening - Suspicion of neoplasm associated with the study ulcer or any non-study diabetic ulcer independent of biopsy result. - Presence of any cellulitis not localized to the study ulcer. - Indwelling hardware at the site of the DFO. - Body weight <50 kg. - Presence of above ankle ulcer, with >50% above medial malleolus - Hemoglobin < 7g/dL - Abnormal liver function tests - History of underlying liver disease at screening or within last 3 months - Positive test for HIV-1 and /or HIV-2 - 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. - More than 30 days has elapsed between screening and randomization (start of treatment) - 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. - Once approximately 30% of subjects are enrolled with DFO involving digits, additional subjects will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Phage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Other:
Placebo
Placebo (normal saline)

Locations

Country Name City State
United States Rocky Mountain VA Aurora Colorado
United States Advanced Specialty Research Boise Idaho
United States James J. Peters VA Bronx New York
United States South Lake Pain Institute Clermont Florida
United States Midland Florida Clinical Research Center DeLand Florida
United States Cardio Voyage / Texoma Health Denison Texas
United States Henry Ford Health Detroit Michigan
United States NorthBay Healthcare Fairfield California
United States Holy Cross Health Fort Lauderdale Florida
United States University of Florida Health - Jacksonville Jacksonville Florida
United States BioSolutions Clinical Research Center La Mesa California
United States Central Arkansas Veteran's Healthcare System Little Rock Arkansas
United States Futuro Clinical Trials, LLC McAllen Texas
United States LCC Medical Research Miami Florida
United States Floridian Clinical Research Miami Lakes Florida
United States Jersey Shore University Medical Center Neptune New Jersey
United States Podiatry 1st / Gateway Clinical Trials O'Fallon Illinois
United States Foot and Ankle Specialists of the Mid-Atlantic Salem Virginia
United States Salem VA Salem Virginia
United States Bio X Cell Research LLC San Antonio Texas
United States Infectious Disease Consultants od the Treasure Coast Sebastian Florida
United States Foot & Ankle Center of Illinois Springfield Illinois
United States Holy Name Medical Center Teaneck New Jersey
United States Harbor Hospital / UCLA Torrance California
United States Compass Medical Research Tucson Arizona
United States Southern Arizona VA Health Care System Tucson Arizona
United States Nextstage Tulsa Tulsa Oklahoma
United States MedStar Washington Hospital Center Washington District of Columbia
United States CurAlta Foot and Ankle Westwood New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Adaptive Phage Therapeutics, Inc. United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Treatment-emergent AEs due to phage therapy Number and percent of treatment-emergent Adverse Events baseline through Week 12
Primary Percent area reduction of study ulcer through Week 13 Percent area reduction of the study ulcer surface area from baseline through Week 13 Baseline through Week 13
Secondary Complete healing of the study ulcer Time to complete healing of the ulcer at any time point during the study Baseline through Week 13
Secondary Time to 85% reduction of C-reactive protein (CRP) Time to 85% reduction of CRP at any time point during the study Baseline through Week 13
Secondary Microbiological eradication of the target pathogen Percentage of patients with microbiological eradication of the target pathogen at each time point during the study. baseline through Week 13
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