Leishmaniasis Clinical Trial
Official title:
Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis
Verified date | December 2019 |
Source | U.S. Army Medical Research and Development Command |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
visceral 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 primary objective of this
protocol is to collect safety data on the use of Pentostam for treatment of
laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral
and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days.
Due to low enrollment, the protocol was later amended in version 11 submitted 19May2010 in
serial no. 0096) to remove the efficacy objective and only collect safety data for enrolled
subjects. Prior to this amendment, data were entered on case report forms (CRFs). Per the
Sponsor's discretion, CRFs were no longer required and protocol-specified treatment details
and safety assessments were recorded in the patients' medical records (study file) only. No
data entry or statistical analyses of patient data was conducted.
Status | Completed |
Enrollment | 77 |
Est. completion date | April 2015 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. DoD healthcare beneficiary of any age and gender. 2. Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection. 3. Able to provide informed consent or assent (children). 4. 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: 1. Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period. 2. History of hypersensitivity to pentavalent antimonials. 3. 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/mm^3) 7. White blood cell count < 2000 / mm^3 8. Hematocrit < 30 % |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Development Command | Walter Reed Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required. | prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28 | |
Primary | Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events | The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required. | prior to infusion on days 2) 5, 10, 15, 20, 25, and 28 |
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