• Final Cure six months after the end of treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  

Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15). At two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.

Number of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-65 years).

Lack of suitability for the trial:

• Post Kala-azar Dermal Leishmaniasis (PKDL)
• Concomitant treatment with other anti-leishmanial drugs
• Any condition which compromises ability to comply with the study procedures

Administrative reasons:

• Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication, dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.

Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)

Dosage:

1. weighing ≥ 25 kg: 100 mg miltefosine daily as one capsule (50 mg) in the morning and one capsule in the evening, after meals for 14 days.

2. weighing < 25 kg: 50 mg miltefosine daily as one capsule (50 mg) in the morning, after meals for 14 days. Parameter for evaluation

   • Final cure rate (initial parasite cure and clinical assessment at six month EOT)
   • Initial parasitological cure rate (based on splenic aspirates or Bone marrow aspirate)
   • Clinical response at end of treatment (clinical assessment)
   • Adverse events

Statistical methods

• Calculation of cure rate with 95% and 90% lower confidence limit according to Clopper Pearson
• Calculation of overall incidence of adverse events