- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01083511
Collection and Extraction of Respiratory Specimens
Collection & Extraction of Respiratory Specimens for the Validation of the Artus Influenza RG PCR Test
Přehled studie
Postavení
Podmínky
Detailní popis
Each year the morbidity and mortality associated with respiratory tract infections fluctuates seasonally. This rise and fall is associated with the changing prevalence of respiratory viruses in the population. Myriad respiratory viruses are responsible for these infections. For example, Influenza Virus, Respiratory Syncytial Virus (RSV), Parainfluenza Virus, Human Metapneumovirus, Rhinovirus, and Adenovirus have all been identified as causing such infections. Numerous pathogenic subtypes have been identified within most of these viral groups. Apart from supportive measure (e.g., bed rest, hydration, etc.), there are no effective treatments for these viral infections; however, antiviral agents (e.g.,Tamiflu) can be used to alleviate the severity of flu-like symptoms.
Each year the virus population fluctuates, and with it the antigenic presentation of the dominant strains that circulate through the population. Epidemics arise when larger and larger portions of the population do not have innate or acquired resistance to such strain(s) in a given season. The World Health Organization (WHO) maintains a separate website dedicated to tracking outbreaks of influenza, especially avian influenza (https://www.who.int/fluvirus_tracker). Influenza outbreaks monitored in the hope that a pandemic similar to the Spanish Flu of 1918 can be avoided; it is estimated that well over 25 million people died from the Spanish Flu. The United States government also maintains a separate website with resources regarding the flu and pandemic related information (http://www.pandemicflu.gov/). On June 11, 2009 the WHO raised the pandemic threat level to 6 in response to the global appearance of a new strain of swine Influenza A (subtype H1N1). The rapidity with which the H1N1 virus has spread exemplifies the notion that quickly and accurately identifying a viruses associated with an outbreak is critical to global public health.
In the present study a collection of respiratory specimens that are well characterized will be archived for later evaluation using the artus® Influenza RG PCR test. The artus Influenza test is a real-time PCR test that identifies Influenza A, Influenza B, and Influenza Type A/subtype H1N1 from nasopharyngeal swab specimens.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Arizona
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Tucson, Arizona, Spojené státy, 85719
- University of Arizona
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- The University of North Carolina at Chapel Hill
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Ohio
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Columbus, Ohio, Spojené státy, 43210
- Ohio State University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Subjects that sign the Informed Consent form required for prospectively enrolling patients into the study.
- Subjects that present at a hospital, clinic, or physician's office with symptoms of a respiratory tract infection.
- Subjects with an acute respiratory infection where said acute respiratory infection is suspected of being caused by an Influenza virus.
Exclusion Criteria:
- Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 7 days (i.e., ≥7).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Symptomatic
Individuals with signs and symptoms of a respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Presence of Influenza Virus
Časové okno: Specimens will be taken within 7 days of the appearance of symptoms.
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To confirm the presence of Influenza virus in nasopharyngeal specimens taken from individuals having influenza like symptoms.
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Specimens will be taken within 7 days of the appearance of symptoms.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C09-INFLUENZA-002
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