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).
Phase:
Phase 2
Details
Lead Sponsor:
U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command