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
| Tracking Information | |||||
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| First Received Date ICMJE | September 25, 2008 | ||||
| Last Updated Date | January 15, 2013 | ||||
| Start Date ICMJE | January 2004 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00760500 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES Primary objective:
Secondary objectives
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Nasopharyngeal specimen taken by swab |
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| 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). |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Nasopharyngeal Swab
Nasopharyngeal Swab |
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| Study Group/Cohort (s) | 1
Intervention: Procedure: Nasopharyngeal Swab |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 16000 | ||||
| Estimated Completion Date | September 2014 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00760500 | ||||
| Other Study ID Numbers ICMJE | SIVFRC, N01AI70005 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | St. Jude Children's Research Hospital | ||||
| Study Sponsor ICMJE | St. Jude Children's Research Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | St. Jude Children's Research Hospital | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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