Efficacy of monthly treatment with oral fluralaner (Bravecto® 1-Month) against Tunga penetrans in dogs in Brazil: a randomized, double-blind, controlled field study.

BACKGROUND: Tungiasis is a neglected tropical disease caused by the adult female sand flea (Tunga penetrans). Dogs are considered important reservoirs of T. penetrans in Brazil. The aim of this study was to determine the monthly insecticidal efficacy of a single oral administration of fluralaner at a dose of 10-18 mg/kg (Bravecto® 1-Month, also registered as Defenza® in some countries; MSD Animal Health) in dogs naturally infested with T. penetrans. METHODS: This clinical trial was conducted in a rural community located in Ilhéus, Bahia, Brazil. A total of 64 dogs were selected and distributed in a completely randomized design between a treated group (TG) that received one single dose of Bravecto® 1-Month (Defenza®) and a negative control group (CG) that received no treatment. Each group was composed of 32 dogs. The evaluations took place on days 0, 7 ± 2, 14 ± 2, 21 ± 2, 28 ± 2, 35 ± 2, and 42 ± 2 post treatment, in which the dogs were inspected to evaluate the infestation stage and classify lesions associated with tungiasis. The primary efficacy was determined from the percentage of treated dogs free of fleas (stage II and III lesions) after administration of the formulation at each evaluation time. Secondary efficacy was based on the number of active lesions (stages II and III) in each group at each evaluation time. The clinical condition of the animals was defined based on the Severity Score for Acute Dog Tungiasis (SCADT), which is related to the number and severity of lesions. RESULTS: The primary efficacy of the product was greater than 95.0% from days 7 to 21 and reached 100.0% between days 28 and 42, with a significant association between treatment and infestation decline (P < 0.025) between days 7 and 42. Secondary drug efficacy was greater than 99.9% from days 7 to 21, reaching 100.0% between days 28 and 42 (P < 0.05). The treated dogs also scored lower on the SCADT than the control animals did during the entire clinical evaluation period (P < 0.05). CONCLUSIONS: A single administration of Bravecto® 1-Month (Defenza®) was effective in eliminating Tunga penetrans infestations, as well as in preventing parasitism for at least 42 days after treatment.

Efficacy of oral fluralaner (Bravecto) against Tunga penetrans in dogs: A negative control, randomized field study in an endemic community in Brazil.

The sand flea Tunga penetrans is one of the zoonotic agents of tungiasis, a parasitic skin disease of humans and animals. The dog is one of its main reservoirs. This negatively controlled, randomized, double-masked clinical trial evaluated the therapeutic and residual efficacy of fluralaner for treatment of dogs naturally infested with T. penetrans. Sixty-two dogs from an endemically affected community in Brazil were randomly assigned to either receive oral fluralaner (Bravecto chewable tablets) at a dose of 25 to 56 mg fluralaner/kg body weight, or no treatment (31 dogs per group). Dogs were clinically examined using a severity score for acute canine tungiasis (SCADT), parasitological examinations as defined by the Fortaleza classification, and pictures of lesions on days 0 (inclusion and treatment), 7 ± 2, 14 ± 2, 21 ± 2, 28 ± 2, 60 ± 7, 90 ± 7, 120 ± 7 and 150 ± 7. The percentage of parasite-free dogs after treatment was >90% between days 14 and 90 post-treatment with 100% efficacy on study days 21, 28 and 60. Sand flea counts on fluralaner treated dogs were significantly lower (p<0.025) than control dogs on all counts from day 7 to 120. The number of live sand fleas on treated dogs was reduced by > 90% on day 7, > 95% on days 14 and 90, and 100% from day 21 to 60, and with a significant difference between groups from day 7 to 120. From day 7 to day 120, mean SCADT scores were significantly reduced in treated dogs with a mean of 0.10 compared to 1.54 on day 120 in untreated dogs. Therefore, a single oral fluralaner administration is effective for treating and achieving long lasting (> 12 weeks) prevention for tungiasis in dogs.