This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.
The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11
Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
Kimalel Health Centre
Kimalel, Kenya
Kassab Hospital
Kassāb, Al Qaḑārif, Sudan
El Hassan Centre for Tropical Medicine
Doka, Gedarif, Sudan
Initial cure: proportion cured at Day 28
Time frame: Day 28
Final cure: proportion cured at day 210
Time frame: 6 months post treatment
Adverse events and serious adverse events occurring in the three study arms
Time frame: up to day 60
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