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Host Response to Infection and Treatment in Lymphatic Filarial Disease in India

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Institutes of Health Clinical Center (CC).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342576
First received: June 19, 2006
Last updated: November 20, 2012
Last verified: December 2011
  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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1500
Study Start Date: April 1994
Detailed Description:

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
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342576

Contacts
Contact: V. Kumaraswami, Ph.D. Not Listed
Contact: Thomas B Nutman, M.D. (301) 496-5398 tnutman@niaid.nih.gov

Locations
India
Tuberculosis Research Centre Recruiting
Chennai, India
Sponsors and Collaborators
Investigators
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 November 25, 2014