• 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, Koert; Kumar Das, Asish; Ahmed, Be-Nazir; den Boer, Margriet; Almeida, Patrick; Verputten, Meggy; MSF-Holland, Amsterdam, The Netherlands; MSF-Holland, Fulbaria, Bangladesh; CDC, (DGHS); MSF-Holland, Amsterdam, The Netherlands; MSF-Holland, Dhaka, Bangladesh; MSF-Holland, Amsterdam, The Netherlands (2014-06)
      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.