Sodium Stibogluconate Treatment of Leishmaniasis
This study has been completed.
Sponsor:
U.S. Army Medical Research and Materiel Command
Collaborator:
Walter Reed Army Medical Center
Information provided by:
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00662012
First received: April 15, 2008
Last updated: March 21, 2011
Last verified: March 2011
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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)
|
Show Detailed Description 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:
- QTc interval greater or equal to 0.5 sec
- Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias)
- History of recurrent pancreatitis
- Liver failure or active hepatitis with transaminases > 3x upper limit of normal
- Renal failure or creatinine > 2.5 mg/dL
- Thrombocytopenia (platelets <100,000/mm3)
- White blood cell count < 2000 / mm3
- 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: | Robert E. Miller, PhD, Sponsor Representative, Director, Division of Regulated Activities and Compliance, USAMRMC, USAMMDA |
| ClinicalTrials.gov Identifier: | NCT00662012 History of Changes |
| Other Study ID Numbers: | A-10950, WU#01-19002 |
| Study First Received: | April 15, 2008 |
| Last Updated: | March 21, 2011 |
| 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 |
Schistosomicides Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents |
ClinicalTrials.gov processed this record on May 22, 2013