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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Infection||Drug: MBN-101 Drug: Placebo||Phase 1|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
Other Name: BisEDT
Placebo Comparator: Vehicle
MBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate
Other Name: Vehicle
- 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)
- 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).
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
|United States, California|
|Limb Preservation Platform, Inc|
|Fresno, California, United States, 93710|
|United States, Texas|
|Futuro Clinical Trials, LLC|
|McAllen, Texas, United States, 78501|