Collection and Testing of Respiratory Samples

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT01302418
First received: February 18, 2011
Last updated: May 22, 2012
Last verified: May 2012
Results First Received: March 23, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: QIAGEN ResPlex II Advanced Panel
Influenza A
Influenza B
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 A, Influenza B,
Intervention: Device: artus Influenza A/B RT-PCR Test

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Symptomatic  
STARTED     272  
COMPLETED     254  
NOT COMPLETED     18  
Protocol Violation                 9  
Non-evaluable                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Baseline Measures
    Symptomatic  
Number of Participants  
[units: participants]
  272  
Age  
[units: participants]
 
<=18 years     202  
Between 18 and 65 years     66  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  14  ± 16.1  
Gender  
[units: participants]
 
Female     126  
Male     146  
Region of Enrollment  
[units: participants]
 
United States     272  



  Outcome Measures

1.  Primary:   Detection of Respiratory Viruses   [ Time Frame: Specimens will be taken within 5 days of the appearance of symptoms. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Tony Lam
Organization: QIAGEN
phone: 301-944-7090
e-mail: tony.lam@qiagen.com


No publications provided


Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT01302418     History of Changes
Other Study ID Numbers: C10-INFLUENZA-001
Study First Received: February 18, 2011
Results First Received: March 23, 2012
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration