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

NCT00255567 Phase 3 COMPLETED

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.

Details

Lead sponsor	Drugs for Neglected Diseases
Phase	Phase 3
Status	COMPLETED
Enrolment	1142
Start date	2004-11
Completion	2010-01

Conditions

• Visceral Leishmaniasis

Interventions

• Sodium Stibogluconate
• Paromomycin sulphate
• SSG and Paromomycin sulphate

Primary outcomes

• parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear. — 6 months post treatment

Countries

Ethiopia, Kenya, Sudan, Uganda