Visceral Leishmaniasis Clinical Trial
Official title:
A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia, Kenya and Sudan
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.
Currently in the three countries, Sudan, Kenya and Ethiopia many of the patients present
themselves in remote areas and need to be treated in relative resource poor settings. It is
for this reason that standardised treatment with proven efficacy is much needed. A shorter
course of treatment is not only advantageous for the patient but also reduces the overall
case load in the clinics thus reducing the risk of disease outbreaks in already
immuno-compromised kala-azar patients. Paromomycin, either alone or in combination with SSG
would decrease the treatment duration substantially. An additional added value of
combination therapy is that it is likely to reduce the chances of development of parasite
resistance against the individual drugs.
Leishmaniasis experts in the three countries are in agreement that there are potential
benefits of the combination treatment of SSG and PM and that its efficacy should be
evaluated with the view to introduce this protocol if proven efficacious and safe. There is
ample circumstantial evidence of the use of this combination therapy and its efficacy and
tolerability as a standardized protocol. This can only be confirmed through a randomised
controlled study with 6 months follow up.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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