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:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00508963

First received: July 27, 2007

Last updated: December 12, 2014

Last verified: December 2014

History of Changes

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:

MedlinePlus related topics: Leishmaniasis

Genetic and Rare Diseases Information Center resources: Leishmaniasis

U.S. FDA Resources

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

Intervention Details:

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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Biopsy proven new world cutaneous or mucocutaneous leishmania

Exclusion Criteria:

Prolonged QT
Liver disease
Pancreatitis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00508963 History of Changes
Other Study ID Numbers:	UCSF Infectious Diseases
Study First Received:	July 27, 2007
Last Updated:	December 12, 2014
Health Authority:	United States: Food and Drug Administration

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 Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic	Antimony Sodium Gluconate Anthelmintics Anti-Infective Agents Antiparasitic Agents Antiplatyhelmintic Agents Antiprotozoal Agents Pharmacologic Actions Schistosomicides Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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