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Clinical Evaluation of QFlu Combo Test

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Cellex, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
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

January 6, 2012
January 9, 2012
November 2010
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01506583 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of QFlu Combo Test
Clinical Evaluation of QFlu Combo Test

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.

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.

Observational
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample

There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).

  • Cough
  • Myalgia
  • Nasal Obstruction
  • Sore Throat
  • Headache
  • Fatigue
  • Fever
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
July 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
United States
 
NCT01506583
Cellex002, 2R44AI082728-02
No
Cellex, Inc.
Cellex, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Cellex, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP