- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00342576
Host Response to Infection and Treatment in Lymphatic Filarial Disease in India
17. juli 2019 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
Host Response to Infection and Treatment in Lymphatic Filarial Disease Strongyloidiasis in India
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Chennai, Indien
- Tuberculosis Research Centre
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
23. april 1994
Studieafslutning
15. juli 2019
Datoer for studieregistrering
Først indsendt
19. juni 2006
Først indsendt, der opfyldte QC-kriterier
19. juni 2006
Først opslået (Skøn)
21. juni 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2019
Sidst verificeret
15. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9999890048
- OH89-I-0048
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .