China Case Control Avian Influenza

May 29, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Matched Case-Control Study of Risk Factors for Human Infection With Avian Influenza A (H5N1) Virus, China

This study will determine risk factors of human infection with avian influenza A virus, also known as bird flu virus. Certain risk factors such as exposure to poultry, travel history, health status, and other factors may affect one's risk of getting bird flu. Study participants will include individuals, older than age 1, that tested positive for influenza A (H5N1) in a previous surveillance program and controls (individuals that have not tested positive for avian influenza A (H5N1) and have no fever or respiratory symptoms). There will be 1 study visit during which volunteers will be asked detailed questions about their health, work, and travel habits. Study participants will be asked to donate a blood sample to test for antibodies, the part of the blood that fights infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is a matched case-control study of risk factors for human infection with avian influenza A (H5N1) virus in China. The primary study objective is to determine the risk factors for avian influenza A (H5N1) virus infection in humans, in China, whether or not the subject was symptomatic. The confirmed case-patients and confirmed antibody positive avian influenza A (H5N1) persons (asymptomatic or sub-clinical) identified by the previously done National Surveillance Program will be included in this study as cases. Controls will be identified from population registries in villages with rural cases and in the adjacent apartment buildings of the urban cases' residences. If the National Surveillance Program identifies healthcare workers infected with avian influenza A (H5N1) virus, healthcare workers in the same department of the healthcare facilities in which the cases worked will also be included as controls. A matched case-control study will be conducted with a ratio of 4 controls per 1 case. Cases and controls who meet the eligibility criteria will be consented and enrolled in the study. After enrollment a questionnaire will be administered to obtain information on demographic characteristics, underlying diseases, daily activities, shopping habits, poultry raising in the backyard, poultry vaccination, exposure to sick/dead poultry or healthy appearing poultry, visits to places where live poultry were kept (e.g., poultry stalls, retail markets, wholesale markets or poultry farms) in the week before illness, eating habits, food preparation activities related to poultry, children's activities such as playing with poultry and swimming in water with water fowl, exposure to other animals including wild birds, and exposure to other humans with respiratory illnesses or confirmed H5N1 case-patients. Survived cases, individuals whose specimen H5N1 tested positive in previous National Surveillance Program and controls will be asked to provide a blood sample to determine whether they have antibodies to H5N1. New confirmed cases and controls will be asked to donate a blood sample for H5N1 antibody testing. Any control that tests positive will become a case and additional controls will be identified. All samples will be tested for H5N1 antibodies with hemagglutination inhibition (using horse red blood cells) and microneutralization assay. If all negative, the individual will be considered sero-negative; if all positive, the individual will be considered sero-positive for the purposes of this study; if results from hemagglutination inhibition (HI) and microneutralization (MN) assays are discordant, the MN result will be considered the final result (negative or positive). Appropriate antigens for the assays will be selected based on the antigenic characteristics of the virus circulating in the region at the time of sample collection. HI and MN assays will be performed according to accepted SOPs. The study will be completed within one year.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Bejing, China, 100050
        • Chinese Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants should be informed and assent to participate in this study. For children, informed consent should be provided by their parents or legal guardians. Children aged from 10 years old to 18 years old will be asked to assent.

  • Adults or children older than 1 year old.
  • Satisfying above definition of cases and controls

Exclusion Criteria:

  • Infants younger than 12 months

  • For any cases or controls who need proxy, they should be excluded under below situations:

    1. Proxy can not provide sufficient information for this study, or
    2. Proxy refuses to participate in this study, or
    3. No suitable proxy can be found.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06-0070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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