Intradermal immunotherapy with a heat-killed actinomycetales bacterin preparation as adjunctive treatment for canine oomycoses: a multicentric, randomized, controlled, clinical trial

Dr. Domenico Santoro with Brody, a participant in a dermatology study.
Dr. Domenico Santoro with Brody, a participant in a dermatology study.

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with cutaneous and/or gastrointestinal oomycoses

Inclusion criteria: Dogs with cutaneous and gastrointestinal pythiosis if they have compatible clinical signs of cutaneous and/or gastrointestinal pythiosis. The clinical diagnosis will be confirmed by histopathological (immunohistochemistry), microbiological (culture) and immunologically/molecular analysis (ELISA and/or PCR). In addition, in order to be enrolled, dogs will have undergone a previous surgical resection with disease recurrence, surgical resection is not recommended because of location, or owners will have declined recommendations of surgical resection for naturally occurring untreated disease.

Treatment:  Participants will receive an injection into the skin every 3 weeks for a year, for a total of 17 study visits. Complete examination will be performed at each visit. This is a controlled study, dogs maybe assigned to the treatment group which they will receive injections of G. bronchialis  or a Placebo group which will receive injections of placebo (saline). Injection sites will be rotated at each visit. The study does allow the use of medications to treat Pythium like mefenoxam, terbinafine, and glucocorticoids.

Exclusion criteria: Current or recent use of steroids and no Pythium

Cost: The study will pay for each visit, the injections of heat-killed bacteria, the abdominal ultrasound (if indicated), local anesthesia and/or sedation (if indicated), the skin biopsies and blood collections. No other costs will be covered. The study will not cover for routine CBC and chemistry (monthly evaluation of organs function) and medication.

Contacts: You can contact our Small Animal Hospital at (352) 392-2235 or email: VM-ClinicalStudies@ufl.edu to schedule an appointment with Clinical Trials.

Background: Many therapeutic options have been studied in dogs affected by pythiosis (a type of fungus-like disease). These include, but are not limited to, surgical resection, antifungals, pesticides, antibiotics and glucocorticoids. However, the response to treatment is still poor. Very recently, the use of heat-killed bacteria (like actinomycetales) has shown potential beneficial effects on canine allergies. Allergies and pythiosis potentially share common inflammatory and immune response.

 

 

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