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A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI

Primary Purpose

Diabetic Foot Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MBN-101

Placebo

About this trial

This is an interventional treatment trial for Diabetic Foot Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria
Has a foot infection as defined by the IDSA guidelines, with a severity rating of moderate or severe
Either no current or recent (within 72 hours) antibiotic therapy for the DFI,
Has documented adequate arterial perfusion in the affected limb (either palpable dorsalis pedis or posterior tibial pulses, or normal Doppler wave forms, or a toe blood pressure ≥ 45 mm Hg, or an ankle-brachial index (ABI) of >0.6)

Exclusion Criteria:

Proven or highly suspected, involvement of bone (i.e., osteomyelitis)
More than one concurrent, infected, diabetic foot ulcer
Hemoglobin A1c > 11 on the day of presentation
Requirement for ongoing immunosuppressive therapy (topical or inhaled corticosteroids are permitted)
Serum creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase >2 times the upper limit of the normal range of the local testing laboratory
Absolute neutrophil count <1000
Any condition that has required treatment with any other bismuth containing compound within the last 2 weeks (i.e., Kaopectate or Pepto-Bismol)
Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months
Need for any surgical therapy beyond debridement to treat the diabetic foot ulcer (e.g., incision and drainage, removal of necrotic tissue)
Planned lower extremity amputation that will include their infected ulcer
Known allergy to bismuth and/or MBN-101 excipients (methylcellulose, Tween 80 (polysorbate 80))
Female patients who are pregnant, lactating, or who have a positive serum human chorionic gonadotropin (pregnancy) as determined by laboratory testing
Immunocompromised due to illness or organ transplant
History of any type of cancer (excluding non-melanoma localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix)
History of major medical noncompliance
Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results

Sites / Locations

Limb Preservation Platform, Inc
Futuro Clinical Trials, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MBN-101

Vehicle

Arm Description

MBN-101: a suspension of 150, 375, or 600 microgram (µg)/milliliter (mL) (w:v) BisEDT drug particles in suspension in 3% methylcellulose / 0.5% polysorbate 80 / 10 millimole (mM) sodium chloride / 10 mM sodium phosphate.

MBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate

Outcomes

Primary Outcome Measures

Proportion of participants with treatment-related adverse events

Safety and tolerability will be assessed by treatment-related adverse events

Proportion of participants who are clinically cured

Clinical cure is defined as the resolution of clinical signs and symptoms of infection 2 weeks following the end of treatment (EOT)

Secondary Outcome Measures

Proportion of participants who are microbiologically cured

Microbiological cure is defined as the eradication of baseline pathogens 2 weeks following the end of treatment (EOT).

Full Information

NCT ID

NCT02723539

First Posted

March 11, 2016

Last Updated

June 30, 2020

Sponsor

Microbion Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02723539

Brief Title

A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI

Official Title

A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of Adjunctive Treatment With Topically Applied MBN-101 in Patients With Moderate to Severe Diabetic Foot Infection (DFI)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

March 6, 2017 (Actual)

Primary Completion Date

November 1, 2017 (Actual)

Study Completion Date

July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Microbion Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. All patients will also receive systemic antibiotic treatment.

Detailed Description

This is a randomized, double-blind, placebo-controlled, multi-center study that will be conducted in two parts. In Part I, patients will be enrolled into escalating dose cohorts (150, 375, or 600 µg/mL) (N=16/cohort) at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients with diabetes mellitus and a foot infection with an Infectious Disease Society of America (IDSA) infection severity rating of moderate or severe will be eligible for the trial. Both inpatients and outpatients are eligible if they meet all inclusion/exclusion criteria, however all enrolled patients must remain in-hospital for the first 24 hours after initial dosing. Patients with a need for surgical therapy (e.g., incision and drainage or removal of necrotic tissue) beyond standard bedside wound debridement should not be enrolled. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. The determination to stop topical antibiotic therapy will be at the discretion of the principal investigator, and should be based on the resolution of findings of infection. All patients will also receive systemic antibiotic treatment based on the protocol defined algorithm. Systemic antibiotic therapy should continue until, but not beyond, the resolution of findings of infection, as outlined in the 2012 IDSA clinical practice guideline for the diagnosis and treatment of diabetic foot infections,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MBN-101

Arm Type

Experimental

Arm Description

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

MBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate

Intervention Type

Drug

Intervention Name(s)

MBN-101

Other Intervention Name(s)

BisEDT

Intervention Description

Topical application

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Vehicle

Intervention Description

Topical application

Primary Outcome Measure Information:

Title

Proportion of participants with treatment-related adverse events

Description

Safety and tolerability will be assessed by treatment-related adverse events

Time Frame

From the start of dosing upto 4 weeks following the completion of dosing

Title

Proportion of participants who are clinically cured

Description

Clinical cure is defined as the resolution of clinical signs and symptoms of infection 2 weeks following the end of treatment (EOT)

Time Frame

2 weeks following completion of dosing (up to 5 weeks)

Secondary Outcome Measure Information:

Title

Proportion of participants who are microbiologically cured

Description

Microbiological cure is defined as the eradication of baseline pathogens 2 weeks following the end of treatment (EOT).

Time Frame

2 weeks following completion of dosing (up to 5 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria Has a foot infection as defined by the IDSA guidelines, with a severity rating of moderate or severe Either no current or recent (within 72 hours) antibiotic therapy for the DFI, Has documented adequate arterial perfusion in the affected limb (either palpable dorsalis pedis or posterior tibial pulses, or normal Doppler wave forms, or a toe blood pressure ≥ 45 mm Hg, or an ankle-brachial index (ABI) of >0.6) Exclusion Criteria: Proven or highly suspected, involvement of bone (i.e., osteomyelitis) More than one concurrent, infected, diabetic foot ulcer Hemoglobin A1c > 11 on the day of presentation Requirement for ongoing immunosuppressive therapy (topical or inhaled corticosteroids are permitted) Serum creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase >2 times the upper limit of the normal range of the local testing laboratory Absolute neutrophil count <1000 Any condition that has required treatment with any other bismuth containing compound within the last 2 weeks (i.e., Kaopectate or Pepto-Bismol) Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months Need for any surgical therapy beyond debridement to treat the diabetic foot ulcer (e.g., incision and drainage, removal of necrotic tissue) Planned lower extremity amputation that will include their infected ulcer Known allergy to bismuth and/or MBN-101 excipients (methylcellulose, Tween 80 (polysorbate 80)) Female patients who are pregnant, lactating, or who have a positive serum human chorionic gonadotropin (pregnancy) as determined by laboratory testing Immunocompromised due to illness or organ transplant History of any type of cancer (excluding non-melanoma localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix) History of major medical noncompliance Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results

Facility Information:

Facility Name

Limb Preservation Platform, Inc

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Futuro Clinical Trials, LLC

City

McAllen

State/Province

Texas

ZIP/Postal Code

78501

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI

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