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Trial record 2 of 2 for:    mbn-101

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

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ClinicalTrials.gov Identifier: NCT02723539
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Microbion Corporation

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Infection Drug: MBN-101 Drug: Placebo Phase 1

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,


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBN-101
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.
Drug: MBN-101
Topical application
Other Name: BisEDT

Placebo Comparator: Vehicle
MBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate
Drug: Placebo
Topical application
Other Name: Vehicle




Primary Outcome Measures :
  1. Proportion of participants with treatment-related adverse events [ Time Frame: From the start of dosing upto 4 weeks following the completion of dosing ]
    Safety and tolerability will be assessed by treatment-related adverse events

  2. Proportion of participants who are clinically cured [ Time Frame: 2 weeks following completion of dosing (up to 5 weeks) ]
    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 :
  1. Proportion of participants who are microbiologically cured [ Time Frame: 2 weeks following completion of dosing (up to 5 weeks) ]
    Microbiological cure is defined as the eradication of baseline pathogens 2 weeks following the end of treatment (EOT).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723539


Locations
United States, California
Limb Preservation Platform, Inc
Fresno, California, United States, 93710
United States, Texas
Futuro Clinical Trials, LLC
McAllen, Texas, United States, 78501
Sponsors and Collaborators
Microbion Corporation

Responsible Party: Microbion Corporation
ClinicalTrials.gov Identifier: NCT02723539     History of Changes
Other Study ID Numbers: MBN-101-202
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Diabetic Foot
Focal Infection
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies