Sodium Stibogluconate Treatment of Leishmaniasis

NCT00662012 | Completed Phase 2 Results

• 2 other identifiers: A-10950WU#01-19002
• Study Type: interventional
• Target: 414
• 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 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).

Conditions

Leishmaniasis

Keywords

Leishmaniasis; Sodium stibogluconate; Pentostam; sand fly

Outcome Measures

Primary Outcomes (1)

• The Primary Safety Endpoint - Frequency of Complications of Therapy

  The primary safety endpoint is the frequency of complications of therapy

  5 years

Secondary Outcomes (1)

• Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .

  5 years

Study Arms (1)

Sodium Stibogluconate (SSG) 20 mg/kg

EXPERIMENTAL

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with 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 for less responsive; 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)

Sodium Stibogluconate (SSG) 20 mg/kg

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/mm3)
• White blood cell count \< 2000 / mm3
• Hematocrit \< 30 %

Sponsors & Collaborators

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

Study Sites (1)

Walter Reed Army 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

Results Point of Contact

• Title: Naomi Aronson, MD
• Organization: Uniformed Services University of Health Sciences (USUHS)

naomi.e.aronson.civ@mail.mil

(301) 295-3621

Study Officials

• Glenn Wortmann, MD

  Walter Reed Army Medical Center, Infectious Disease

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 21, 2008
• Study Start: June 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 12, 2021
• Results First Posted: March 9, 2017

Record last verified: 2021-02

Locations

US (1)