Sodium Stibogluconate Treatment of Leishmaniasis - Full Text View

Sponsors and Collaborators:	U.S. Army Medical Research and Materiel Command Walter Reed Army Medical Center
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00662012

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 II

MedlinePlus related topics: Leishmaniasis

Drug Information available for: Sodium stibogluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis

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
One: Experimental 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.

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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

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:	USAMRMC, USAMMDA ( Robert E. Miller, PhD, Sponsor Representative, Director, Division of Regulated Activities and Compliance )
Study ID Numbers:	A-10950, WU#01-19002
Study First Received:	April 15, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00662012 History of Changes
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

Study placed in the following topic categories:

Abelcet
Leishmaniasis
Amphotericin B
Protozoan Infections
Skin Diseases, Infectious

Antimony Sodium Gluconate
Skin Diseases
Anthelmintics
Parasitic Diseases
Liposomal amphotericin B

Additional relevant MeSH terms:

Leishmaniasis
Anti-Infective Agents
Protozoan Infections
Antiprotozoal Agents
Skin Diseases, Parasitic
Skin Diseases
Antiplatyhelmintic Agents
Mastigophora Infections
Anthelmintics

Schistosomicides
Pharmacologic Actions
Skin Diseases, Infectious
Antiparasitic Agents
Antimony Sodium Gluconate
Therapeutic Uses
Sarcomastigophora Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 07, 2009