Back to results

Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

Primary Purpose

Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous

Status

Available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

sodium stibogluconate (Pentostam)

About this trial

This is an expanded access trial for Leishmaniasis, Cutaneous focused on measuring New World Cutaneous or Mucocutaneous Leishmaniasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

Biopsy proven new world cutaneous or mucocutaneous leishmania

Exclusion Criteria:

Prolonged QT
Liver disease
Pancreatitis

Sites / Locations

University of CA at San Francisco Hospitals and Clinics

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00508963

First Posted

July 27, 2007

Last Updated

March 6, 2020

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00508963

Brief Title

Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

Official Title

Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

Study Type

Expanded Access

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

5. Study Description

Brief Summary

Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous

Keywords

New World Cutaneous or Mucocutaneous Leishmaniasis

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

sodium stibogluconate (Pentostam)

Intervention Description

20 mg/kg IV every day for 20 or 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: Biopsy proven new world cutaneous or mucocutaneous leishmania Exclusion Criteria: Prolonged QT Liver disease Pancreatitis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jane E Koehler, MA, MD

Phone

415-476-3536

jkoehler@medicine.ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Schwartz, MD

Organizational Affiliation

University of CA at San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kanade Shinkai, MD

Organizational Affiliation

University of CA at San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of CA at San Francisco Hospitals and Clinics

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Available

12. IPD Sharing Statement

Learn more about this trial

Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

We'll reach out to this number within 24 hrs