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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 July 2012 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: July 17, 2012
Last verified: July 2012
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
U.S. FDA Resources

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

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
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: July 17, 2012
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
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
 Antimony Sodium Gluconate
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents

ClinicalTrials.gov processed this record on May 16, 2013