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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 11, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE March 3, 2017
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02723539 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI
Official Title  ICMJE 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)
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,

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Infection
Intervention  ICMJE
  • Drug: MBN-101
    Topical application
    Other Name: BisEDT
  • Drug: Placebo
    Topical application
    Other Name: Vehicle
Study Arms  ICMJE
  • 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.
    Intervention: Drug: MBN-101
  • Placebo Comparator: Vehicle
    MBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
48
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2016)
88
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02723539
Other Study ID Numbers  ICMJE MBN-101-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Microbion Corporation
Study Sponsor  ICMJE Microbion Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Microbion Corporation
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP