Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR

H1N1 Influenza Virus Clinical Trial

Official title:

Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01277380
• Other study ID #: 99029
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 12, 2011
• Last updated: January 13, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: January 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The first outbreak of a new H1N1 influenza pandemic originated in the North America in April 2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around the world and the mortality rate of was about 0.43%. Alignment and analysis on gene sequences of the new H1N1 influenza virus found that it contains extremely homologous gene composition with that of the swine influenza viruses (swine flu) identified in Europe and North America in last century. Thus the virus strain was later renamed as a novel influenza H1N1. In general, the symptoms caused by the new influenza H1N1 infection was very similar to those resulted from seasonal influenza viral infection. Thus, it is difficult to distinguish the various influenza strains responsible for the infections only by clinical appearance. To compare the accuracy, specificity and sensitivity and speed in identifying the new influenza H1N1 in suspected cases, the investigators extracted RNA from influenza A-positive reactive specimens identified by a Influenza Rapid Test, for a Real-time PCR method to further detect the presence of swine H1 gene. In addition, the titer of H1N1 virus, the color development on the test stripe and clinical symptoms in patients were significantly associated. Finally, Real-time PCR products were subjected to sequence determination to explore potential new influenza pathogenicity, transmissibility and drug usage.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Influenza Rapid Test Influenza A(+) B(-)

• Influenza Rapid Test Influenza A(+) B(+)

• Influenza Rapid Test Influenza A(-) B(-) was negative control

Exclusion Criteria:

• Influenza Rapid Test Influenza A(-) B(+)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• H1N1 Influenza Virus
• Influenza, Human

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan,