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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00342576
Collaborator
(none)
1,500
1
302.7
5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Detailed Description

    This study is designed to determine the presence of and the immune response to filarial and stronglyloides infections in an area endemic for both infections in South India. This study will aim to examine the presence of filarial and Strongyloides stercoralis 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 and immunopathology. Careful observations of the individual s 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 as well as the immunology of strongyloides infection.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Host Response to Infection and Treatment in Lymphatic Filarial Disease Strongyloidiasis in India
    Study Start Date :
    Apr 23, 1994
    Study Completion Date :
    Jul 15, 2019

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 75 Years
      Sexes Eligible for Study:
      All
      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

      Locations

      Site City State Country Postal Code
      1 Tuberculosis Research Centre Chennai India

      Sponsors and Collaborators

      • National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

      • Principal Investigator: Thomas B Nutman, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      National Institute of Allergy and Infectious Diseases (NIAID)
      ClinicalTrials.gov Identifier:
      NCT00342576
      Other Study ID Numbers:
      • 9999890048
      • OH89-I-0048
      First Posted:
      Jun 21, 2006
      Last Update Posted:
      Jul 18, 2019
      Last Verified:
      Jul 15, 2019
      Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Jul 18, 2019