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

The University of Florida College of Veterinary Medicine is not currently recruiting dogs diagnosed with cutaneous oomycoses (the study is also closed to patients diagnosed with intestinal oomycoses).

Enrollment Status: Enrollment Closed

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.

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

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 doctors will prescribe medications to treat Pythium, such as mefenoxam and terbinafine. The study does allow the use of glucocorticoids after enrollment if the doctor sees fit.

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.

Contact: This study is currently closed.

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.