Sodium Stibogluconate Treatment of Leishmaniasis
Condition: Leishmaniasis
MeSH terms: Leishmaniasis
Intervention: Sodium Stibogluconate (SSG)
Intervention description: 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; 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.
Intervention MeSH terms: Antimony Sodium Gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 414.0
Sex: All
Healthy volunteers: No
Keywords: Leishmaniasis; Sodium stibogluconate; Pentostam; sand fly

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  DoD healthcare beneficiary of any age and gender.

          -  Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of
             Leishmania infection.

          -  Able to provide informed consent or assent (children).

          -  All participants (both male and female) must agree to take precautions not to become
             pregnant or father a child for at least 2 months after receiving SSG.

        Exclusion Criteria:

          -  Pregnancy. Females of childbearing potential must have negative urine human chorionic
             gonadotropin hormone (HCG) within 96 hours start of infusion period.

          -  History of hypersensitivity to pentavalent antimonials.

          -  Any of the following on screening examination:

               1. QTc interval greater or equal to 0.5 sec

               2. Severe cardiac disease (disabling valvular heart disease, myopathy, or
                  arrhythmias)

               3. History of recurrent pancreatitis

               4. Liver failure or active hepatitis with transaminases > 3x upper limit of normal

               5. Renal failure or creatinine > 2.5 mg/dL

               6. Thrombocytopenia (platelets <100,000/mm3)

               7. White blood cell count < 2000 / mm3

               8. Hematocrit < 30 %