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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
  Purpose

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
Cough
Myalgia
Nasal Obstruction
Sore Throat
Headache
Fatigue
Fever

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Evaluation of QFlu Combo Test

Resource links provided by NLM:


Further study details as provided by Cellex, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Samples were retained in case that the testing needs to be repeated. They are to be discarded 12 months after the study is completed.


Estimated Enrollment: 1000
Study Start Date: November 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506583

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: David Kimberlin, M.D.    205-934-5316    dkimberlin@peds.uab.edu   
Contact: Dusty Giles, R.N.    205-934-7807    dgiles@peds.uab.edu   
Principal Investigator: David Kimberlin, M.D.         
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 61611
Contact: Mike Ison, M.S., M.D.    312-695-4186    mgison@northwestern.edu   
Principal Investigator: Mike Ison, M.S., M.D.         
United States, Maryland
University of Maryland School of Medicine Completed
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Cellex, Inc.
  More Information

No publications provided

Responsible Party: Cellex, Inc.
ClinicalTrials.gov Identifier: NCT01506583     History of Changes
Other Study ID Numbers: Cellex002, 2R44AI082728-02
Study First Received: January 6, 2012
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cellex, Inc.:
cough
myalgia
nasal obstruction
sore throat
headache
fatigue
feverishness
Patients who exhibit flu-like symptoms during a flu season, including cough, myalgia, nasal obstruction, sore throat, headache, fatigue, and/or feverishness.

Additional relevant MeSH terms:
Cough
Fatigue
Headache
Nasal Obstruction
Pharyngitis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 23, 2014