Clinical trial NCT05177107: Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteomyelitis
Diabetic Foot Osteomyelitis
Keywords: Diabetes
Osteomyelitis
Foot Infection
Phage Treatment
Bacteriophage
Phage
Bone Infection
Lead sponsor: Adaptive Phage Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2022-01-04
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1, phage: placebo
Primary purpose: TREATMENT

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

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.

Eligibility 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 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.

Primary outcomes:
measure: Percent area reduction of study ulcer through Week 13
timeFrame: Baseline through Week 13
Secondary outcomes:
measure: Complete healing of the study ulcer
timeFrame: Baseline through Week 13
measure: Time to 85% reduction of C-reactive protein (CRP)
timeFrame: Baseline through Week 13
measure: Microbiological eradication of the target pathogen
timeFrame: baseline through Week 13
Other outcomes:
measure: Treatment-emergent AEs due to phage therapy
timeFrame: baseline through Week 12
Locations:
city: Tucson
country: United States
facility: Compass Medical Research
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Healthcare System
state: Arkansas
city: Fairfield
country: United States
facility: NorthBay Healthcare
state: California
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: Torrance
country: United States
facility: Harbor Hospital / UCLA
state: California
city: Aurora
country: United States
facility: Rocky Mountain VA
state: Colorado
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Clermont
country: United States
facility: South Lake Pain Institute
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Health
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health - Jacksonville
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: LCC Medical Research
state: Florida
city: Sebastian
country: United States
facility: Infectious Disease Consultants od the Treasure Coast
state: Florida
city: Boise
country: United States
facility: Advanced Specialty Research
state: Idaho
city: O'Fallon
country: United States
facility: Podiatry 1st / Gateway Clinical Trials
state: Illinois
city: Springfield
country: United States
facility: Foot & Ankle Center of Illinois
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Westwood
country: United States
facility: CurAlta Foot and Ankle
state: New Jersey
city: Bronx
country: United States
facility: James J. Peters VA
state: New York
city: Tulsa
country: United States
facility: Nextstage Tulsa
state: Oklahoma
city: Denison
country: United States
facility: Cardio Voyage / Texoma Health
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Bio X Cell Research LLC
state: Texas
city: Salem
country: United States
facility: Foot and Ankle Specialists of the Mid-Atlantic
state: Virginia
city: Salem
country: United States
facility: Salem VA
state: Virginia
Study officials:
affiliation: Chief Medical Officer
name: Edward Fang, MD
role: PRINCIPAL_INVESTIGATOR
References: