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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Type A
Influenza Type B
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2008-09-26
Enrollment: 13201
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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).

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: This is an epidemiologic study, there is no time frame.
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: First Affiliated Hospital
state: Guangdong
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Miguela Caniza, MD
role: PRINCIPAL_INVESTIGATOR
References: