Clinical Investigation of Infections Due to Leishmanial Parasites

Leishmaniasis Clinical Trial

Official title:

Clinical Investigation of Infections Due to Leishmanial Parasites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001169
• Other study ID #: 790144
• Secondary ID: 79-I-0144
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: December 1979
• Est. completion date: February 2001

Study information

• Verified date: February 2000
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Mechanisms of host immune response to intracellular protozoa will be investigated in patients with naturally acquired infection employing a variety of in-vitro techniques. Both non-specific and antigen-specific humoral and cellular immune responses will be assessed. Parasites will be isolated from patients, cultivated in-vitro, and characterized. Responses to chemotherapy will be assessed parasitologically, immunologically and clinically.

Description:

The main purpose of this protocol is to permit us to see patients who are referred to us for diagnosis and treatment of known or suspected leishmaniasis (from the Peace Corps, Smithsonian Institution, tourists, etc.). In the process of working up these patients, we sometimes encounter parasite isolates that are useful for research. We also can perform tests of cell-mediated immune function to evaluate how patients are responding to therapy. In addition, the protocol permits us to observe therapeutic responses to other drugs besides pentavalent antimony, if necessary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older
• Eligibility: Must be between the ages of 1 and 65 years.

Study Design

N/A

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral

Locations

Country	Name	City	State
United States	National Institute of Allergy and Infectious Diseases (NIAID)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Badaro R, Falcoff E, Badaro FS, Carvalho EM, Pedral-Sampaio D, Barral A, Carvalho JS, Barral-Netto M, Brandely M, Silva L, et al. Treatment of visceral leishmaniasis with pentavalent antimony and interferon gamma. N Engl J Med. 1990 Jan 4;322(1):16-21. — View Citation

Ponce C, Ponce E, Morrison A, Cruz A, Kreutzer R, McMahon-Pratt D, Neva F. Leishmania donovani chagasi: new clinical variant of cutaneous leishmaniasis in Honduras. Lancet. 1991 Jan 12;337(8733):67-70. — View Citation

Velasco O, Savarino SJ, Walton BC, Gam AA, Neva FA. Diffuse cutaneous leishmaniasis in Mexico. Am J Trop Med Hyg. 1989 Sep;41(3):280-8. — View Citation