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Sodium Stibogluconate Treatment of Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00662012
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Leishmaniasis Drug: Sodium Stibogluconate (SSG) Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sodium Stibogluconate Treatment of Leishmaniasis
Study Start Date : June 2002
Primary Completion Date : October 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sodium Stibogluconate (SSG) 20 mg/kg
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Drug: Sodium Stibogluconate (SSG)
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.
Other Name: Pentostam (GlaxoSmithKline)

Outcome Measures

Primary Outcome Measures :
  1. The Primary Safety Endpoint - Frequency of Complications of Therapy [ Time Frame: 5 years ]
    The primary safety endpoint is the frequency of complications of therapy

Secondary Outcome Measures :
  1. Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions . [ Time Frame: 5 years ]
    Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 %
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662012

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Principal Investigator: Glenn Wortmann, MD Walter Reed Army Medical Center, Infectious Disease
More Information

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00662012     History of Changes
Other Study ID Numbers: A-10950
WU#01-19002 ( Other Identifier: WRAIR )
First Posted: April 21, 2008    Key Record Dates
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Walter Reed Army Medical Center

Keywords provided by U.S. Army Medical Research and Materiel Command:
Sodium stibogluconate
sand fly

Additional relevant MeSH terms:
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiplatyhelmintic Agents