Osteomyelitis Clinical Trial
— DANCEOfficial 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
This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Adaptive Phage Therapeutics, Inc. | United States Department of Defense |
United States,
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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