Clinical Investigation of Infections Due to Leishmanial Parasites

Completed

• Conditions: Leishmaniasis; Leishmaniasis, Visceral

• Registration Number: NCT00001169
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study Start: 1979-12
• Study First Submitted: 1999-11-03
• Status Verified: 2000-02
• Study Completion: 2001-02
• Study First Submitted QC: 2002-12-09
• Study First Posted: 2002-12-10
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institute of Allergy and Infectious Diseases (NIAID); 🇺🇸 Bethesda, Maryland, United States