Host Response to Infection and Treatment in Lymphatic Filarial Disease in India
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Purpose
Patients admitted on this protocol will have, or be suspected of having, one of the lymphatic filarial infections affecting humans. After routine clinical evaluation they will be studied in depth immunologically, and their blood cells and/or serum will be collected to provide reagents (eg., specific antibodies, T cell clones, etc.) that will be used in the laboratory to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. It is anticipated both that the patients will receive optimal clinical care for their infections and that the specimens collected from them will prove to be valuable reagents for the laboratory studies of the immunologic responses unique to filarial or other helminthic infections.
| Condition |
|---|
|
Lymphatic Filarial Disease |
| Study Type: | Observational |
| Official Title: | Host Response to Infection and Treatment in Lymphatic Filarial Disease in India |
| Estimated Enrollment: | 1500 |
| Study Start Date: | April 1994 |
This study is designed to determine the presence of and the immune response to filarial infections in an area endemic for lymphatic filariasis in South India. This study will aim to examine the presence of filarial infection at a community level as well as in hospital settings. After routine clinical evaluation and screening, individuals enrolled in this protocol will be studied in depth immunologically, and their blood cells and/or serum will be collected to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and immunoprophylaxis. Careful observations of the individuals' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. In addition to infected individuals, this protocol will also be used to study individuals with filarial pathology and endemic normal individuals. This will enable us to characterize the immunological profiles of infected, uninfected and diseased individuals in an endemic area and provide greater insight into the pathogenesis of lymphatic filarial disease.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Age 18-75 years.
Ability to give informed consent.
EXCLUSION CRITERIA:
Pregnant or nursing women will be excluded from the treatment arm of the study.
Less than 18 years of age; greater than 75 years of age.
Contacts and Locations| Contact: V. Kumaraswami, Ph.D. | Not Listed | |
| Contact: Thomas B Nutman, M.D. | (301) 496-5398 | tnutman@niaid.nih.gov |
| India | |
| Tuberculosis Research Centre | Recruiting |
| Chennai, India | |
| Principal Investigator: | Thomas B Nutman, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00342576 History of Changes |
| Other Study ID Numbers: | 9999890048, OH89-I-0048 |
| Study First Received: | June 19, 2006 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Filarial Parasites Wuchereria Bancrofti Brugia Malayi Diethylcarbamazine (DEC) Ivermectin |
ClinicalTrials.gov processed this record on June 17, 2013