Use of Sodium Stibogluconate as a Treatment for Leishmaniasis
Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and visceral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The primary objective of this protocol is to collect safety and efficacy data on the use of Pentostam for treatment of laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis|
- The primary safety endpoint is the frequency of complications of therapy. The primary efficacy endpoint is the clinical response to treatment of cutaneous, mucocutaneous, or visceral leishmaniasis: clinical cure, early failure, or relapse failure. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment only
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).
Drug: Sodium Stibogluconate (SSG)
100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Other Name: Pentostam (GlaxoSmithKline)
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|United States, District of Columbia|
|Walter Reed National Military Medical Center|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator:||Roseanne Ressner, MD||Walter Reed National Military Medical Center, Infectious Disease|