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

NCT ID: NCT00342576

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1994-04-23
• Study Completion Date: 2019-07-15

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.

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.

Conditions

Lymphatic Filarial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas B Nutman, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Tuberculosis Research Centre

Chennai, , India

Countries

India

References

Piessens WF, Partono F, Hoffman SL, Ratiwayanto S, Piessens PW, Palmieri JR, Koiman I, Dennis DT, Carney WP. Antigen-specific suppressor T lymphocytes in human lymphatic filariasis. N Engl J Med. 1982 Jul 15;307(3):144-8. doi: 10.1056/NEJM198207153070302.

Reference Type: BACKGROUND

PMID: 6178026 (View on PubMed)

Nutman TB, Kumaraswami V, Pao L, Narayanan PR, Ottesen EA. An analysis of in vitro B cell immune responsiveness in human lymphatic filariasis. J Immunol. 1987 Jun 1;138(11):3954-9.

Reference Type: BACKGROUND

PMID: 3295043 (View on PubMed)

Nutman TB, Kumaraswami V, Ottesen EA. Parasite-specific anergy in human filariasis. Insights after analysis of parasite antigen-driven lymphokine production. J Clin Invest. 1987 May;79(5):1516-23. doi: 10.1172/JCI112982.

Reference Type: BACKGROUND

PMID: 3553242 (View on PubMed)

Other Identifiers

OH89-I-0048

Identifier Type: -

Identifier Source: secondary_id

9999890048

Identifier Type: -

Identifier Source: org_study_id