CoughQFluNCT01506583
Clinical Evaluation of QFlu Combo Test
An observational study of Cough and Myalgia, run by Cellex, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cough, Myalgia, Nasal Obstruction
- How many people
- 506 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2010to 31 May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).
Who may be able to join
- Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 61611
About this study
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.
Read the 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.
- Conditions
- Cough, Myalgia, Nasal Obstruction, Sore Throat, Headache, Fatigue
- Keywords
- 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.
- Medical subject headings
- Cough, Myalgia, Nasal Obstruction, Pharyngitis, Headache, Fatigue, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for drug resistance detection
Interim results may be assessed after the first year study.
Measured: approximately 12 months after the study is completed.
Secondary outcomes (1)
Sensitivity and Specificity of the Test for Influenza Diagnosis
Results may be assessed after the first year study.
Measured: 12 months after the study is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study start1 Nov 2010
- Primary completion31 May 2012
- Study completion31 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506583
- Sponsor's protocol ID
- Cellex002
- Other IDs
- 2R44AI082728-02
- Acronym
- QFlu
- Status last verified
- Aug 2021
- First submitted
- 6 Jan 2012
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of QFlu Combo Test
- ClinicalTrials.gov ID
- NCT01506583
- Acronym / sponsor ID
- QFlu / Cellex002
- Conditions
- Cough, Myalgia, Nasal Obstruction, Sore Throat, Headache, Fatigue
- Keywords
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Cellex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Nov 2010
- Primary completion
- 31 May 2012 (actual)
- Study completion
- 31 May 2012 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).
Key inclusion criteria (1 listed)
- Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity for drug resistance detection
Time frame: approximately 12 months after the study is completed.
Interim results may be assessed after the first year study.
1 secondary outcome
Sensitivity and Specificity of the Test for Influenza Diagnosis
Time frame: 12 months after the study is completed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough and Myalgia, run by Cellex, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity for drug resistance detection (time frame: approximately 12 months after the study is completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.