We detail the design of a study to monitor the safety of including albendazole to an existing treatment regimen to eliminate lymphatic filariasis. We wish to show that this new regimen does not increase the rate of a rare serious adverse event (SAE) compared to the old regimen. Controlled but small clinical trials have not detected any increase in the SAE using albendazole, and it is known to have added benefits; therefore, it is unethical to randomize patients to the old regimen.
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, Bethesda, MD 20892-7609, USA. mfay@niaid.nih.gov
