Influenza Type ANCT00760500
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
An observational study of Influenza Type A and Influenza Type B, run by St. Jude Children's Research Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Influenza Type A, Influenza Type B
- What is being tested?
- Nasopharyngeal Swab
- How many people
- 13,201 participants
- Where
- 1 siteChina
- Study dates
- Jan 2004to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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.
Who cannot join
- Patient is too ill to tolerate a nasopharyngeal specimen swab.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Influenza Type A, Influenza Type B
- Being tested
- Nasopharyngeal Swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal SwabOther
Nasopharyngeal Swab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Nasopharyngeal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This is an epidemiologic study, there is no time frame.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJan 2004
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Type AStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 13,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Miguela Caniza, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760500
- Sponsor's protocol ID
- SIVFRC
- Other IDs
- N01AI70005
- Status last verified
- Feb 2015
- First submitted
- 25 Sep 2008
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00760500
- Acronym / sponsor ID
- SIVFRC
- Conditions
- Influenza Type A, Influenza Type B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,201 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- The University of Hong Kong, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2004
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Nasopharyngeal Swab |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient is too ill to tolerate a nasopharyngeal specimen swab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal SwabNasopharyngeal Swab | Other | 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguela Caniza, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Type A and Influenza Type B, run by St. Jude Children's Research Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: This is an epidemiologic study, there is no time frame.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.