Clinical Evaluation of QFlu Combo Test

NCT ID: NCT01506583

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

506 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-01

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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General population

This group of participants is primarily an out-patient population.

No interventions assigned to this group

In-patient population

This group of participants is primarily an in-patient population.

No interventions assigned to this group

Pediatric Group

Participants in this group are children 18 years or younger.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Cellex, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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2R44AI082728-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Cellex002

Identifier Type: -

Identifier Source: org_study_id

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