Use of Sodium Stibogluconate as a Treatment for Leishmaniasis

NCT00657618 | Completed Phase 1 Results

• 3 other identifiers: A-12631WU#04-19011Pentostam
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Leishmaniasis

Keywords

Leishmaniasis, Sodium stibogluconate, Pentostam, sand fly

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Treatment only

EXPERIMENTAL

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)

Interventions

Sodium Stibogluconate (SSG) DRUG

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.

Also known as: Pentostam (GlaxoSmithKline)

Treatment only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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/mm\^3)
• White blood cell count \< 2000 / mm\^3
• Hematocrit \< 30 %

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Medical Center: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Leishmaniasis

Interventions

Antimony Sodium Gluconate; halofantrine

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Limitations and Caveats

Due to low enrollment protocol was amended to remove efficacy objective and only collect safety data. No data entry or statistical analyses of patient data was conducted.

Results Point of Contact

• Title: Roseanne A. Resnner, MD
• Organization: WRAIR

rose.resnner@us.armyh.mil

301-295-6400

Study Officials

• Roseanne Ressner, MD

  Walter Reed National Military Medical Center, Infectious Disease

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: October 1, 2004
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2015
• Last Updated: January 2, 2020
• Results First Posted: February 27, 2018

Record last verified: 2019-12

Locations

US (1)