Clinical Evaluation of QFlu Combo Test

Sponsor

Cellex, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01506583

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

506

Enrollment

Locations

Duration (Months)

168.7

Patients Per Site

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever

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 Design

Study Type:

Observational

Actual Enrollment :

506 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of QFlu Combo Test

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

May 31, 2012

Actual Study Completion Date :

May 31, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity for drug resistance detection [approximately 12 months after the study is completed.]
Interim results may be assessed after the first year study.

Secondary Outcome Measures

Sensitivity and Specificity of the Test for Influenza Diagnosis [12 months after the study is completed.]
Results may be assessed after the first year study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	61611
3	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201