- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00760500
Surveillance of Influenza Virus Among Children With Febrile Respiratory Complaints Attending the Pediatric Clinic of the First Affiliated Hospital, Shantou University Medical College, Shantou, Guangdong, Mainland China
February 16, 2015 updated by: St. Jude Children's Research Hospital
The surveillance of influenza virus among children with febrile reparatory complaints attending the pediatric clinic in Shantou is an epidemiologic study to identify the type (influenza A or B) and the subtype of Influenza A of the isolates from children with febrile respiratory complaints who attend the pediatric clinic of the first Affiliated Hospital, Shantou University Medical College, Shantou Guangdong, China.
Also this study investigates the genetic composition of all segments of isolated strains using standard molecular techniques and to make available the new strains of influenza viruses isolated from such children for the formulation of influenza vaccines.
Clinical manifestation of the respiratory illness is recorded and single nasopharyngeal swab is obtained from eligible children.
Viral culture is performed on the nasopharyngeal secretions.
If influenza is isolated, this is characterized if it belongs to influenza A or B. If the virus is characterized as influenza A, further antigenic studies is done to determine subtype of influenza.
Viral isolates is further studied to determine the genetic composition of the virus.
Information obtained from the viral isolates is shared with the WHO and the CDC.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES
Primary objective:
- To identify the type (Influenza A or B) and the subtype of Influenza A of the isolates from children with febrile respiratory complaints who attend the pediatric clinic of the First Affiliated Hospital, Shantou University Medical College, Shantou, Guangdong, China.
Secondary objectives
- To investigate the genetic composition of all segments of isolated strains using standard molecular techniques.
- To make available the new strains of influenza viruses isolated from such children for the formulation of influenza vaccines.
Study Type
Observational
Enrollment (Actual)
13201
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
-
-
Guangdong
-
Shantou, Guangdong, China, 515041
- First Affiliated Hospital
-
-
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
Ages Eligible for Study
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children between the ages of 0 months and 18 years (inclusive) who have been seen at the pediatric clinic of the First Affiliated Hospital within 7 days of the onset of signs and symptoms of febrile respiratory illness suspected to be of viral origin (temperature > 37.7ºC or reliable history of fever before being examined, and respiratory symptoms and signs such as cough, sore throat, and coryza).
Description
Inclusion Criteria:
- Age: 0 day to 18 years.
- Patient was seen at the pediatric clinic of the First Affiliated Hospital within 7 days of the onset of signs and symptoms of febrile respiratory illness suspected to be of viral origin (temperature > 37.7ºC or reliable history of fever before being examined, and respiratory symptoms and signs such as cough, sore throat, and coryza).
- Parents agree to a nasopharyngeal specimen being taken by swab from their child.
Exclusion Criteria:
- Patient is too ill to tolerate a nasopharyngeal specimen swab.
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
|
Nasopharyngeal Swab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify Influenza A or B and the subtype of Influenza A of the isolates from children with febrile respiratory complaints who attend the pediatric clinic of the First Affiliated Hospital, Shantou University Medical College.
Time Frame: This is an epidemiologic study, there is no time frame.
|
This is an epidemiologic study, there is no time frame.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Miguela Caniza, MD, St. Jude Children's Research Hospital
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.
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
January 1, 2004
Primary Completion (ACTUAL)
March 1, 2014
Study Completion (ACTUAL)
March 1, 2014
Study Registration Dates
First Submitted
September 25, 2008
First Submitted That Met QC Criteria
September 25, 2008
First Posted (ESTIMATE)
September 26, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 18, 2015
Last Update Submitted That Met QC Criteria
February 16, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIVFRC
- N01AI70005 (OTHER_GRANT: NIAID)
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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