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Use of Sodium Stibogluconate as a Treatment for Leishmaniasis

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ClinicalTrials.gov Identifier: NCT00657618
Recruitment Status : Completed
First Posted : April 14, 2008
Results First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

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 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.


Condition or disease Intervention/treatment Phase
Leishmaniasis Drug: Sodium Stibogluconate (SSG) Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis
Actual Study Start Date : October 2004
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
Experimental: Treatment only
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (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)




Primary Outcome Measures :
  1. Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience [ Time Frame: prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28 ]
    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.

  2. Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events [ Time Frame: prior to infusion on days 2) 5, 10, 15, 20, 25, and 28 ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 %

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657618


Locations
United States, District of Columbia
Walter Reed National Military 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: Roseanne Ressner, MD Walter Reed National Military Medical Center, Infectious Disease

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00657618     History of Changes
Other Study ID Numbers: A-12631
WU#04-19011 ( Other Identifier: IRB )
Pentostam ( Registry Identifier: NCT00657618 )
First Posted: April 14, 2008    Key Record Dates
Results First Posted: February 27, 2018
Last Update Posted: February 27, 2018
Last Verified: January 2018

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
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics