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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Influenza Type A Influenza Type B |
Procedure: Nasopharyngeal Swab |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | 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 |
- 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. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Nasopharyngeal specimen taken by swab
| Estimated Enrollment: | 16000 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Procedure: Nasopharyngeal Swab
Nasopharyngeal Swab
|
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
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.
Contacts and Locations| Contact: Miguela Caniza, MD | 1-866-278-5833 | info@stjude.org |
| China, Guangdong | |
| First Affiliated Hospital | Recruiting |
| Shantou, Guangdong, China, 515041 | |
| Contact: Yang Lin Ni, MD | |
| Principal Investigator: Yang Lin Ni, M.D. | |
| Principal Investigator: | Miguela Caniza, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00760500 History of Changes |
| Other Study ID Numbers: | SIVFRC, N01AI70005 |
| Study First Received: | September 25, 2008 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013