Safety, efficacy, and pharmacokinetics of an allometric miltefosine regimen for the treatment of visceral leishmaniasis in Eastern African children: an open-label, phase-II clinical trial

by Mbui J, Olobo J, Omollo R, Solomos A, Kip AE, Kirigi G, Sagaki P, Kimutai R, Were L, Omollo T, Egondi TW, Wasunna M, Alvar J, Dorlo TPC, and Alves F. Clinical Infectious Diseases 2018, ciy747, doi: 10.1093/cid/ciy747.

Summary: Miltefosine, the only oral treatment for visceral leishmaniasis, has failed to achieve adequate cure rates in Eastern Africa, particularly in children. For children, linear dosing (2.5 mg/kg/day for 28 days) resulted in a 59% cure rate, with lower systemic miltefosine exposure than in adults. This phase-II trial demonstrated that allometric dosing safely increased the efficacy of miltefosine to 90% for Eastern African children with visceral leishmaniasis. Further development of miltefosine should adopt allometric dosing in paediatric patients.

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