Sodium Stibogluconate Treatment of 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 viseral 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 objective of this protocol is to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal leishmaniasis (pentavalent antimonials curently considered the drug of choice for these infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is FDA approved for vusceral leishmaniasis).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sodium Stibogluconate Treatment of 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 abnormalties for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Study Completion Date:||December 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00662012
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator:||Glenn Wortmann, MD||Walter Reed Army Medical Center, Infectious Disease|