Clinical Trial: Use of Sodium Stibogluconate as a Treatment for Leishmaniasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis

Brief Summary: 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.

Detailed Summary:

Leishmaniasis is a protozoal disease transmitted by sandflies and is endemic in many parts of the world including Central and South America, Europe, Southwest Asia, Africa, and the Middle East. Infected humans may develop cutaneous (Old or New World), mucocutaneous (New World), or visceral leishmaniasis. The disease is a medical threat for military soldiers assigned in endemic areas and currently a major cause of morbidity in soldiers deployed to the Middle East and a complication of military exercises in Panama, Honduras, and South America. Sodium stibogluconate (SSG) is an Investigational New Drug (IND) product that has been in use by the Department of Defense (DoD) for over 20 years for the treatment of cutaneous, mucosal and visceral leishmaniasis. The primary objective of this protocol is to treat 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. Subjects will be monitored daily and outcome measured at the end of therapy by the degree of healing of cutaneous lesions or resolution of laboratory abnormalities and symptoms in the case of mucosal and visceral leishmaniasis.

Pentavalent antimonials (Pentostam, Glaxo Smith Kline, United Kingdom) has been used to treat leishmaniasis for more than 50 years. This drug has not been licensed for commercial use in the United States, likely because of limited commercial marketability. Worldwide and within the DoD, there is a great deal of experience and use of Pentostam for the treatment of leishmaniasis. SSG is a pentavalent antimony (Sb) complexed to a carbohydrate whose exact structure and mechanism of action are not known. It is provided as a 100 mg antimony/mL
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome: Number of adverse events [ Time Frame: 5 years ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

Original Secondary Outcome: 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 ]

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: April 8, 2008
Date Started: October 2004
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017