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Protocol > 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

Ritmeijer KKD
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Abstract
General objective
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.

Primary objective: to evaluate the effectiveness of AmBisome 15 mg/kg total dose at 12 M

Secondary objective:
• Evaluate the safety of AmBisome 3mg/kg x 5 infusions (twice weekly) (15 mg/kg total dose)
• Evaluate the occurrence of hypokalaemia
• Evaluate at which point in time lesions start to respond to treatment.
Subject Area
leishmaniasis
Published Date
01-Jun-2014
Languages
English