Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

Osteomyelitis Clinical Trial

— DANCE  

Official title:

Phase 2b Randomized, Parallel, Double-blind, Placebo-Controlled, Repeat Dose, Multi-Site Study for Safety, Tolerability, and Efficacy of Personalized Phage Treatment and SoC for Subjects With Diabetic Foot Osteomyelitis Due to S. Aureus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177107
• Other study ID #: APT.DFI.001
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Osteomyelitis
• Osteomyelitis

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

External Links

•   Clinical Trial Information Page