Clinical Evaluation of QFlu Combo Test

This study is currently recruiting participants.

Verified January 2012 by Cellex, Inc.

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Cellex, Inc.

ClinicalTrials.gov Identifier:

NCT01506583

First received: January 6, 2012

Last updated: January 9, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 6, 2012
Last Updated Date	January 9, 2012
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 9, 2012)	Sensitivity and specificity for drug resistance detection [ Time Frame: approximately 12 months after the study is completed. ] [ Designated as safety issue: No ] Interim results may be assessed after the first year study.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01506583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 9, 2012)	Sensitivity and Specificity of the Test for Influenza Diagnosis [ Time Frame: 12 months after the study is completed. ] [ Designated as safety issue: No ] Results may be assessed after the first year study.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Evaluation of QFlu Combo Test
Official Title ^ICMJE	Clinical Evaluation of QFlu Combo Test
Brief Summary	Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.
Detailed Description	The study design is to collect samples from participants. A portion of the sample is used for drug resistance detection using the test (QFlu Combo Test) under investigation. The remaining portion of the sample is used for culture. The culture positive samples are used for determination of IC50 values, which is used as a gold standard for defining whether a virus isolate is resistant to a drug or not. The sensitivity and specificity of the QFlu test will be calculated by comparing to the gold standard test.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Samples were retained in case that the testing needs to be repeated. They are to be discarded 12 months after the study is completed.
Sampling Method	Non-Probability Sample
Study Population	There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).
Condition ^ICMJE	Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	General population This group of participants is primarily an out-patient population. In-patient population This group of participants is primarily an in-patient population. Pediatric Group Participants in this group are children 18 years or younger.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	1000
Estimated Completion Date	July 2012
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01506583
Other Study ID Numbers ^ICMJE	Cellex002, 2R44AI082728-02
Has Data Monitoring Committee	No
Responsible Party	Cellex, Inc.
Study Sponsor ^ICMJE	Cellex, Inc.
Collaborators ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Investigators ^ICMJE	Not Provided
Information Provided By	Cellex, Inc.
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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