Sodium Stibogluconate Treatment of Leishmaniasis

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00662012
First received: April 15, 2008
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Leishmaniasis
Drug: Sodium Stibogluconate (SSG)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sodium Stibogluconate Treatment of Leishmaniasis

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 418
Study Start Date: June 2002
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated 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; 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)

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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 %
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662012

Locations
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
Investigators
Principal Investigator: Glenn Wortmann, MD Walter Reed Army Medical Center, Infectious Disease
  More Information

No publications provided

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
Study First Received: April 15, 2008
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leishmaniasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on September 18, 2014