Collection and Extraction of Respiratory Specimens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT01083511
First received: March 8, 2010
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

The study will be conducted with nasopharyngeal swab specimens collected prospectively from individuals suspected of having an acute respiratory tract infection caused by an Influenza virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, as well as the CDC swine H1N1 test will be used to establish a collection of well characterized specimens. For each specimen four (4) aliquots will be prepared. One aliquot will be tested in real-time using the requisite viral culture reference methods, one aliquot will be used for H1N1 reference testing, one aliquot will be used to extract nucleic acid in real-time, and one aliquot of the UTM will be archived for the purpose of sequencing to confirm Influenza-positive specimens. The extracted nucleic acid and any remaining specimen will be stored at -70°C for later testing by the artus Influenza RG PCR test, or other investigational method(s).


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Collection & Extraction of Respiratory Specimens for the Validation of the Artus Influenza RG PCR Test

Resource links provided by NLM:


Further study details as provided by QIAGEN Gaithersburg, Inc:

Primary Outcome Measures:
  • Presence of Influenza Virus [ Time Frame: Specimens will be taken within 7 days of the appearance of symptoms. ] [ Designated as safety issue: No ]
    To confirm the presence of Influenza virus in nasopharyngeal specimens taken from individuals having influenza like symptoms.


Biospecimen Retention:   Samples With DNA

Extracted nucleic acid, Residual Universal Transport Medium.


Enrollment: 600
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population includes individuals having the signs and symptoms of a respiratory tract infection caused by an Influenza virus.

Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083511

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85719
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
QIAGEN Gaithersburg, Inc
  More Information

No publications provided

Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT01083511     History of Changes
Other Study ID Numbers: C09-INFLUENZA-002
Study First Received: March 8, 2010
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by QIAGEN Gaithersburg, Inc:
Influenza
Influenza A
Influenza B
Swine Influenza A/H1N1
Respiratory Virus

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014