Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

Sponsor

Adaptive Phage Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05177107

Collaborator

(none)

126

Enrollment

Locations

Arms

34.2

Anticipated Duration (Months)

25.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2:1, phage: placebo2:1, 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 :

Nov 24, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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)

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

Primary Outcome Measures

Percent area reduction of study ulcer through Week 13 [Baseline through Week 13]
Percent area reduction of the study ulcer surface area from baseline through Week 13

Secondary Outcome Measures

Complete healing of the study ulcer [Baseline through Week 13]
Time to complete healing of the ulcer at any time point during the study
Time to 85% reduction of C-reactive protein (CRP) [Baseline through Week 13]
Time to 85% reduction of CRP at any time point during the study
Microbiological eradication of the target pathogen [baseline through Week 13]
Percentage of patients with microbiological eradication of the target pathogen at each time point during the study.

Other Outcome Measures

Treatment-emergent AEs due to phage therapy [baseline through Week 12]
Number and percent of treatment-emergent Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas Veteran's Healthcare System	Little Rock	Arkansas	United States	72205
2	University of Florida Health - Jacksonville	Jacksonville	Florida	United States	32209
3	Floridian Clinical Research	Miami Lakes	Florida	United States	33016
4	Martin Foot and Ankle	York	Pennsylvania	United States	17402
5	Futuro Clinical Trials, LLC	McAllen	Texas	United States	78501