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

Expanded access is currently available for this treatment.
Verified December 2014 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508963
First Posted: July 30, 2007
Last Update Posted: December 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).

Condition Intervention
Leishmaniasis, Cutaneous Leishmaniasis, Mucocutaneous Drug: sodium stibogluconate (Pentostam)

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Intervention Details:
    Drug: sodium stibogluconate (Pentostam)
    20 mg/kg IV every day for 20 or 28 days
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Biopsy proven new world cutaneous or mucocutaneous leishmania

Exclusion Criteria:

  • Prolonged QT
  • Liver disease
  • Pancreatitis
  Contacts and Locations
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): NCT00508963


Contacts
Contact: Jane E Koehler, MA, MD 415-476-3536 jkoehler@medicine.ucsf.edu

Locations
United States, California
University of CA at San Francisco Hospitals and Clinics
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Brian Schwartz, MD University of CA at San Francisco
Principal Investigator: Kanade Shinkai, MD University of CA at San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00508963     History of Changes
Other Study ID Numbers: UCSF Infectious Diseases
First Submitted: July 27, 2007
First Posted: July 30, 2007
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by University of California, San Francisco:
New World Cutaneous or Mucocutaneous Leishmaniasis

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Leishmaniasis, Mucocutaneous
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