Status:
COMPLETED
Sodium Stibogluconate Treatment of Leishmaniasis
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Leishmaniasis
Eligibility:
All Genders
Phase:
PHASE2
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...
Detailed Description
Leishmaniasis is a protozoal disease transmitted by sandflies and is endemic in many parts of the world including Central and South America, Europe, Southwest Asia, Africa, and the Middle East. Infect...
Eligibility Criteria
Inclusion
- 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
- 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 %
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT00662012
Start Date
June 1 2002
End Date
December 1 2007
Last Update
February 12 2021
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307