Clinical Investigation of Infections Due to Leishmanial Parasites

NCT ID: NCT00001169

Last Updated: 2008-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1979-12-31
• Study Completion Date: 2001-02-28

Brief 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.

Detailed 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.

Conditions

Leishmaniasis; Leishmaniasis, Visceral

Eligibility Criteria

Inclusion Criteria

Must be between the ages of 1 and 65 years.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Locations

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, United States

Countries

United States

References

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. doi: 10.1016/0140-6736(91)90734-7.

Reference Type: BACKGROUND

PMID: 1670724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2802018 (View on PubMed)

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. doi: 10.1056/NEJM199001043220104.

Reference Type: BACKGROUND

PMID: 2104665 (View on PubMed)

Other Identifiers

79-I-0144

Identifier Type: -

Identifier Source: secondary_id

790144

Identifier Type: -

Identifier Source: org_study_id