Collection and Testing of Respiratory Samples
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01302418|
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : June 28, 2012
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment|
|QIAGEN ResPlex II Advanced Panel Influenza A Respiratory Syncytial Virus Infections Infection Due to Human Parainfluenza Virus 1 Parainfluenza Type 2 Parainfluenza Type 3 Parainfluenza Type 4 Human Metapneumovirus A/B Rhinovirus Coxsackie Virus/Echovirus Adenovirus Types B/C/E Coronavirus Subtypes 229E Coronavirus Subtype NL63 Coronavirus Subtype OC43 Coronavirus Subtype HKU1 Human Bocavirus Artus Influenza A/B RT-PCR Test Influenza B||Device: artus Influenza A/B RT-PCR Test|
Each year the morbidity and mortality associated with acute 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 acute infections. Numerous pathogenic subtypes have been identified within most of these viral groups. The outbreak of Severe Acute Respiratory Syndrome (SARS) in 2003 was eventually identified as a Coronavirus; the mortality of SARS among the elderly can be as high as 50%. More recently, Human Bocavirus (HBoV) has also been identified as causing acute respiratory tract infections. In 2005 the HBoV was identified by molecular testing and was found to be the only virus identified in a subpopulation of patients suffering from respiratory tract infections. Apart from supportive measure (e.g., bed rest, hydration, etc.), there are no effective treatments for many of these viral infections; however, antiviral agents (e.g., the neuraminidase inhibitors oseltamivir or zanamivir) can be used to alleviate the severity of flu-like symptoms. Identification of a respiratory virus as the causative agent is important because it eliminates the need for treatment with antibiotics; physicians typically wait 7-10 days for symptoms to alleviate before prescribing antibiotics due to risks associated with exacerbating bacterial antibiotic resistance.
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 immunological 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). These zoonotic transmissions that further adapt to enable human-to-human transmission are of the greatest concern because it is predicted that virtually all humans will be immunologically naïve. Zoonotic transmissions in the human population are 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 viral pathogen associated with an outbreak is critical to global public health.
In addition to the threat of an influenza outbreak, the expansion in the number of viruses that cause acute respiratory tract infections compounds the difficulty in correctly and rapidly identifying the primary pathogen; each new virus or subtype increases the complexity of testing. Molecular diagnostic assays are ideally suited to address this complexity. Assays based on the polymerase chain reaction (PCR) can incorporate multiple primers and probes (e.g., multiplexed) in a single reaction to deal with this complexity.4 Such assays are extremely sensitive, have a high degree of specificity, and can be performed very quickly. The artus Influenza A/B RT-PCR test is a real-time PCR assay for the detection and identification of Influenza A and B, while the QIAGEN ResPlex II Advanced Panel test is a nucleic acid amplification-based assay for the detection and identification of a broad range of some of the most common respiratory viruses associated with acute respiratory tract infections. In the present study respiratory specimens will be prospectively collected and tested using the artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test.
|Study Type :||Observational|
|Actual Enrollment :||272 participants|
|Official Title:||Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||November 2011|
Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
Device: artus Influenza A/B RT-PCR Test
The investigational assay, used for detecting the presence of Influenza A/B.
- Detection of Respiratory Viruses [ Time Frame: Specimens will be taken within 5 days of the appearance of symptoms. ]The presence of Influenza A or Influenza B virus.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302418
|United States, Arizona|
|University of Arizona|
|Tuscon, Arizona, United States, 85719|
|United States, New York|
|Albany Medical College|
|Albany, New York, United States, 12208|
|Wadsworth Center, New York State Department of Health|
|Albany, New York, United States, 12208|
|United States, North Carolina|
|The University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|