Clinical Trial: Sodium Stibogluconate Treatment of Leishmaniasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Sodium Stibogluconate Treatment of 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 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).
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.
Pentavalent antimonials (Pentostam, GSK, UK, and Glucantime, Rhone-Poulenc, France) have been used to treat leishmaniasis for more that 50 years. Neither of these drugs are licensed for commercial use in the United States, likely because of limited use. Worldwide, there is a great deal of experience and use of these products.
Pentostam or sodium stibogluconate is a pentavalent antimony drug complexed to carbohydrate the exact structure and mechanism of action of which are not known. It is provided as a 100 mg antimony/ml solution that contains a preservative, m-chlorocresol. Most of the dose is excreted by the kidneys within 24 hours.
Pentostam is presently 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. In August, 1997, the FDA approved Ambisome (liposomal amphotericin) for the treatment of visceral leishmaniasis. As a result, in the treatment of visceral and viscerotropic leishmaniasis, the use of antimonials will now be considered a second-line therapy
In 1984, the World Health Organization recommended that the daily dose of antimony in the treatment
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome: The Primary Safety Endpoint - Frequency of Complications of Therapy [ 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: Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions . [ Time Frame: 5 years ]
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 15, 2008
Date Started: June 2002
Date Completion:
Last Updated: January 18, 2017
Last Verified: November 2016
