Research Protocol - Post-kala-azar Dermal Leishmaniasis (PKDL): a prospective observational study of the effectiveness and safety of an ambulatory short course treatment with AmBisome* 15 mg/kg total dose

Research protocol.\ud These materials can be used, adapted and copied as long as citation of the source is given including the direct URL to the material. This work is licensed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0/ https://i.creativecommons.org/l/by/4.0/88x31.pngGeneral objective\ud To evaluate the effectiveness and safety of PKDL treatment with AmBisome 15 mg/kg total dose, given over 15 days in 5 infusions (twice weekly) of 3mg/kg on an ambulatory basis in a primary health care setting.\ud \ud Primary objective: to evaluate the effectiveness of AmBisome 15 mg/kg total dose at 12 M\ud \ud Secondary objective: \ud • Evaluate the safety of AmBisome 3mg/kg x 5 infusions (twice weekly) (15 mg/kg total dose) \ud • Evaluate the occurrence of hypokalaemia\ud • Evaluate at which point in time lesions start to respond to treatment