- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302418
Collection and Testing of Respiratory Samples
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 Overview
Status
Conditions
- Respiratory Syncytial Virus Infections
- Influenza A
- Rhinovirus
- Influenza B
- QIAGEN ResPlex II Advanced Panel
- Infection Due to Human Parainfluenza Virus 1
- Parainfluenza Type 2
- Parainfluenza Type 3
- Parainfluenza Type 4
- Human Metapneumovirus A/B
- 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
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Tuscon, Arizona, United States, 85719
- University of Arizona
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New York
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Albany, New York, United States, 12208
- Albany Medical College
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Albany, New York, United States, 12208
- Wadsworth Center, New York State Department of Health
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- The University of North Carolina
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 the signs and 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 5 days (i.e., ≥5).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Symptomatic
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.
|
The investigational assay, used for detecting the presence of Influenza A/B.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Specimens will be taken within 5 days of the appearance of symptoms.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Disease Attributes
- DNA Virus Infections
- Mononegavirales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Orthomyxoviridae Infections
- Pneumovirus Infections
- Coronavirus Infections
- Infections
- Communicable Diseases
- Virus Diseases
- Influenza, Human
- Respiratory Syncytial Virus Infections
- Adenoviridae Infections
- Coxsackievirus Infections
- Paramyxoviridae Infections
Other Study ID Numbers
- C10-INFLUENZA-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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