Back to resultsClinical Investigation of Infections Due to Leishmanial Parasites
Primary Purpose
Leishmaniasis, Leishmaniasis, Visceral
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Leishmaniasis focused on measuring Chemotherapy, Cytokines, Immunology, Kala-Azar, Leishmaniasis
Eligibility Criteria
Must be between the ages of 1 and 65 years.
Sites / Locations
- National Institute of Allergy and Infectious Diseases (NIAID)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001169
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001169
Brief Title
Clinical Investigation of Infections Due to Leishmanial Parasites
Official Title
Clinical Investigation of Infections Due to Leishmanial Parasites
Study Type
Observational
2. Study Status
Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
December 1979 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis, Leishmaniasis, Visceral
Keywords
Chemotherapy, Cytokines, Immunology, Kala-Azar, Leishmaniasis
7. Study Design
Enrollment
250 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Must be between the ages of 1 and 65 years.
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1670724
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. doi: 10.1016/0140-6736(91)90734-7.
Results Reference
background
PubMed Identifier
2802018
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.
Results Reference
background
PubMed Identifier
2104665
Citation
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.
Results Reference
background
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Clinical Investigation of Infections Due to Leishmanial Parasites
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