Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR
| Tracking Information | |||||
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| First Received Date ICMJE | January 12, 2011 | ||||
| Last Updated Date | January 13, 2011 | ||||
| Start Date ICMJE | August 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01277380 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR | ||||
| Official Title ICMJE | Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | H1N1 Influenza |
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| Condition ICMJE | H1N1 Influenza Virus | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | August 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01277380 | ||||
| Other Study ID Numbers ICMJE | 99029 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Giueng-Chueng Wang, Laboratory Medicine, Wanfang Hospital | ||||
| Study Sponsor ICMJE | Taipei Medical University WanFang Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Taipei Medical University WanFang Hospital | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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