Sodium Stibogluconate Treatment of Leishmaniasis

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Collaborator: Walter Reed Army Medical Center
• Treatments: Antimony Sodium Gluconate

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 %