by Verrest L, Kip AE, Musa A, Schoone GJ, Schallig HDFH, Mbui J, Khalil EAG, Younis BM, Olobo J, Were L, Kimutai R, Monnerat S, Cruz I, Wasunna M, Alves F, Dorlo TPC. Clinical Infectious Diseases 2021: ciab124. doi: 10.1093/cid/ciab124.
Summary: In order to expedite the development of new oral treatment regimens for visceral leishmaniasis, there is a need for early markers to evaluate treatment response and predict long-term outcomes. In this study, data from three clinical trials of antileishmanial therapies in Eastern African visceral leishmaniasis patients were analysed and clinical trial simulations were performed to investigate the use of blood parasite load as a surrogate endpoint to predict clinical outcome at six months. Leishmania parasite load in the blood determined by qPCR was found to be a promising early biomarker to predict relapse in visceral leishmaniasis patients. Once optimized, it might be useful in dose finding studies of new chemical entities.