NCT01277380

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 14, 2011

Status Verified

January 1, 2011

First QC Date

January 12, 2011

Last Update Submit

January 13, 2011

Conditions

H1N1 Influenza Virus

Keywords

H1N1 Influenza virusswine fluReal Time RT-PCR

Study Arms (3)

Experimental Group

Control Group

Negative control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

H1N1 Influenza

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Giueng-Chueng Wang

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 14, 2011

Study Start

August 1, 2010

Study Completion

August 1, 2011

Last Updated

January 14, 2011

Record last verified: 2011-01

Locations

TW(1)