- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00428493
Prospective Study of AI H5N1 in China
29. maj 2008 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
Prospective Study of Individuals Exposed to Confirmed Cases of Human Influenza A (H5N1) Infection in China
The purpose of this study is to see if people in China who have contact with someone infected with bird flu (H5N1) become infected themselves without necessarily getting sick.
Adults and children greater than 1 year of age who have contact with someone infected with bird flu may participate in the study.
At the first 1-2 study visits, a blood sample will be taken from volunteers in order to test for antibodies, the part of the blood that fights infection.
If the result of the H5N1 antibody test is positive after the 1st or 2nd study visit, an additional blood sample will be collected during a 3rd and 4th study visit.
Volunteers will be asked questions about their work, home life, and possible contact with poultry, other birds, animals, and people infected with bird flu.
Participants will be involved in study related procedures for up to 90 days.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This will be a prospective cohort study of individuals exposed to confirmed cases of Human Influenza A (H5N1) infection in China.
The study will be conducted over a period of approximately one year.
Adults and children, greater than age 1, who meet the eligibility criteria will be consented and enrolled in the study.
These subjects will undergo up to two blood draws for serologic testing of the presence of H5N1 antibodies according to an algorithm.
These subjects will also be administered a structured questionnaire for collection of demographic information, information on potential exposure to poultry, other birds or animals, or infected humans and any clinical symptoms.
This questionnaire will have similar data elements to the questionnaires used in the past for collection by the China CDC.
The questionnaires were administered in areas of China where there have been poultry and human cases, as well as, other high risk populations in non-outbreak areas.
Enrolled participants will complete two study visits no more than one month apart with a third visit for those who test positive for influenza A H5N1 infection.
Participants who consent to HIV testing will have a fourth visit to obtain their HIV test results.
The primary study objective is to determine the prevalence of antibodies to avian influenza A (H5N1) virus among close contacts and health care workers associated with confirmed H5N1 infected individuals in China.
The secondary study objectives are to: describe risk factors for human infection with avian influenza A (H5N1) virus in China; evaluate the incidence of seroconversion and increases in titer of H5N1 antibodies; describe risk factors associated with seroconversion and increases in titer of H5N1 antibodies; determine T-cell immune responses in H5N1 infected individuals; and determine the prevalence of co-infection of H5N1 and HIV-1.
The primary endpoint is detection of avian influenza H5N1 infection as determined by a positive result on Hemagglutination Inhibition (HI) and confirmed by Microneutralization (MN).
Corresponding with the secondary study objectives, the following will be assessed as secondary study endpoints: association of risk factors with avian influenza seropositivity, including demographic characteristics and various exposures to poultry, other birds, and to infected humans; H5N1 serum antibody titer seroconversion or a greater than or equal to 4-fold increase in titer; association of risk factors with avian influenza seroconversion, including demographic characteristics and various exposures to poultry, other birds, and to infected humans; HIV-1 infection as determined by ELISA and Western Blot assays and co-infection of H5N1 and HIV-1 as determined by both assays described above; and T-cell responses to H5N1 as determined by ELISPOT assay and ICS.
Undersøgelsestype
Observationel
Tilmelding
4000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing, Kina, 100052
- Chinese Center for Disease Control and Prevention
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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
1 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Informed consent for study participation provided by the volunteer or, for children, by a parent or legal guardian. Children aged 10-18 will be asked to assent.
- Adults and children > 1 year old.
- Close contacts or health care worker of confirmed human H5N1 case.
Exclusion Criteria:
1. Children under 12 months old.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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
1. januar 2007
Studieafslutning
1. januar 2008
Datoer for studieregistrering
Først indsendt
25. januar 2007
Først indsendt, der opfyldte QC-kriterier
26. januar 2007
Først opslået (Skøn)
30. januar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. maj 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2008
Sidst verificeret
1. maj 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06-0055
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 .
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