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Home > Scientific articles
Nov 2023

Safety and efficacy of paromomycin/ miltefosine/ liposomal amphotericin B combinations for the treatment of post-kala-azar dermal leishmaniasis in Sudan: A phase II, open label, randomized, parallel arm study

PLOS Neglected Tropical Diseases

by Younis BM, Mudawi Musa A, Monnerat S, Abdelrahim Saeed M, Awad Gasim Khalil E, Elbashir Ahmed A, Ahmed Ali M, Noureldin A, Muthoni Ouattara G, Nyakaya GM, Teshome S, Omollo T, Ochieng M, Egondi T, Mmbone M, Chu W-Y, Dorlo TPC, Zijlstra EE, Wasunna M, Alvar J, Alves F. PLOS Neglected Tropical Diseases 2023, 17(11): e0011780. doi: 10.1371/journal.pntd.0011780

Summary: It is important to treat post-kala-azar dermal leishmaniasis (PKDL) to prevent onward transmission of leishmania parasites. However, in Sudan, treatment is currently recommended only for patients with persistent or severe disease, mainly because current therapies have toxicity and/or require long hospitalization. In this open-label, phase II, randomized, parallel-arm, non-comparative trial, the authors assessed the safety and efficacy of miltefosine combined with paromomycin and with liposomal amphotericin B for the treatment of PKDL in 110 patients in Sudan. The paromomycin/miltefosine regimen was suitably safe and highly efficacious (98.2%) even for moderate and severe PKDL, and could be administered at primary health centres. A liposomal amphotericin B/miltefosine regimen is a good alternative (80% efficacy) for implementation in hospitals for a shorter period.

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Clinical trials Visceral leishmaniasis Africa

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