Diabetic Foot Infection Clinical Trial
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)
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.
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,
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