Use of Sodium Stibogluconate as a Treatment for Leishmaniasis

• Status: Completed
• Trial end date: 2015-04-01
• 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 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 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.

Due to low enrollment, the protocol was later amended in version 11 submitted 19May2010 in serial no. 0096) to remove the efficacy objective and only collect safety data for enrolled subjects. Prior to this amendment, data were entered on case report forms (CRFs). Per the Sponsor's discretion, CRFs were no longer required and protocol-specified treatment details and safety assessments were recorded in the patients' medical records (study file) only. No data entry or statistical analyses of patient data was conducted.

• Phase: Phase 1/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:

1. DoD healthcare beneficiary of any age and gender.

2. Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection.

3. Able to provide informed consent or assent (children).

4. 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:

1. Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period.

2. History of hypersensitivity to pentavalent antimonials.

3. 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/mm^3)

7. White blood cell count < 2000 / mm^3

8. Hematocrit < 30 %