December 2020 saw the completion of "A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali (LeDoxy-Mali)."
The purpose of the study was to evaluate how well the antibiotic doxycycline, when added to intensive hygiene management, alleviated the symptoms of lymphedema caused by the parasitic infection lymphatic filariasis. Left untreated, lymphatic filariasis can lead to lymphedema in the legs – known as elephantiasis – a condition associated with pain, disability, disfigurement, and stigma. The World Health Organization has set a target in its new road map to eliminate lymphatic filariasis as a public health problem in 58 countries by 2030. That goal is based on a global strategy both to distribute donated medicines that prevent spread of the infection and to aggressively manage the clinical manifestations of the disease – especially lymphedema.
LEDoxy aims to help those who were left behind with clinical disease even after transmission of infection was interrupted by the donated medicines. Previous research suggested that doxycycline could prevent not only the progression of lymphedema but could also decrease the frequency one of the most pernicious symptoms of the disease: acute inflammatory attacks caused by infections within folds of skin on the legs. The trial combined the antibiotic approach with training on limb washing and assessed both the frequency of the attacks and the level of swelling. The hope is that – in addition to stopping the acute attacks – the drug will halt the progressive enlargement of affected limbs, and even cause their swelling to go down.
The clinical trial, funded by the United States Agency for International Development (USAID) via the Coalition for Operational Research on Neglected Tropical Diseases (COR-NTD), launched in 2018 with three research sites: in India, Mali, and Sri Lanka. These were joined in parallel by three additional sites in Cameroon, Ghana and Tanzania supported by the German Ministry of Higher Education. Dr. Yaya Coulibaly, a researcher at the International Center for Excellence in Research (ICER-Mali), served as principal investigator for the Mali site.
“After the treatment, a lady who had over the last 15 years had the disease – she couldn’t ride a bicycle – and she was able to ride her bicycle to a neighboring village, 15 kilometers,” said Coulibaly in a brief documentary about the trial produced by The Task Force for Global Health. “She was really amazed and thankful. She’s utterly satisfied with the impact of the drugs and her new treatment.”