Flubendazole 2.0: Designing a large field trial in dogs for a challenging setting.

Dracunculiasis, or Guinea worm disease (GWD), was targeted for eradication in 1986 after which, the annual incidence decreased by over 99.9%. As human cases of GWD near elimination, dogs have become the primary reservoir for the parasite and remain a challenge for eradication efforts. The high burden of GWD in dogs relative to humans highlights the need for therapeutic interventions in conjunction with behavioral interventions. Laboratory experiments in ferrets demonstrated that flubendazole is partially effective in inhibiting the infectivity of D. medinensis larvae. However, the implementation of large clinical field trials in dogs has proven challenging in settings where access to study areas is unreliable throughout the year and attrition is high. Alternative study design approaches are required to address these challenges. This paper outlines challenges encountered during a previous field trial and ways in which these challenges were addressed in the study design and implementation for a second clinical trial of flubendazole in dogs. The results of the second clinical trial are outlined in a separate manuscript.