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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborators:
The University of Hong Kong
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00760500
First received: September 25, 2008
Last updated: July 9, 2014
Last verified: July 2014
  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
Other: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: 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
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760500

Contacts
Contact: Miguela Caniza, MD 1-866-278-5833 info@stjude.org

Locations
China, Guangdong
First Affiliated Hospital Recruiting
Shantou, Guangdong, China, 515041
Contact: Yang Lin Ni, MD         
Principal Investigator: Yang Lin Ni, M.D.         
Sponsors and Collaborators
St. Jude Children's Research Hospital
The University of Hong Kong
Investigators
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: July 9, 2014
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 August 28, 2014