Respiratory Tract InfectionNCT01787227
A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel
An observational study of Respiratory Tract Infection and Bronchitis, run by Luminex Molecular Diagnostics at 4 sites in 2 countries.
Trial summary
xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs). The objective of this study is to establish diagnostic accuracy of the xTAG RPP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infection, Bronchitis, Bronchiolitis
- What is being tested?
- xTAG RPP
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2015to Sep 2015
- 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: Clinical specimens collected from patients with clinical signs and symptoms of respiratory tract infection who are either hospitalized, admitted to emergency departments or visiting outpatient clinics.
Who may be able to join
- The specimen is a nasopharyngeal swab.
- The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
- The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia.
Who cannot join
- The specimen is not a nasopharyngeal swab.
- The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
North Shore-LIJ Health System Laboratories
Lake Success, New York, 11042
St. Louis Children's Hospital
St Louis, Missouri
Scott and White Memorial Hospital
Temple, Texas, 76508
About this study
Official title: A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (NxTAG RPP) in Patients With Clinical Signs and Symptoms of Respiratory Tract Infection
xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs).
The objective of this study is to establish diagnostic accuracy of the xTAG RPP.
- Conditions
- Respiratory Tract Infection, Bronchitis, Bronchiolitis, Pneumonia
- Being tested
- xTAG RPP
- Medical subject headings
- Respiratory Tract Infections, Bronchitis, Bronchiolitis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xTAG RPPDevice
| Study group | Role | What they receive |
|---|---|---|
| Blinded, Pre-selected Arm | For targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested. Receives: Device: xTAG RPP | |
| Blinded, Prospective Arm | Diagnostic accuracy for the more prevalent targets will be evaluated in prospectively collected, de-identified, left-over, clinical specimens accrued during the 2012/2013 flu season. Receives: Device: xTAG RPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target.
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by xTAG RPP.
Measured: Within the first year after sample extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2015
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luminex Molecular Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Liu, Ph.D, Study director, Luminex Molecular DiagnosticsJames Mahony, Ph.D, FCCM, FAAM, Principal investigator, St. Joseph's Health Care LondonRichard Buller, PhD, D (ABMM), Principal investigator, St. Louis Children's HospitalArundhati Rao, M.D., Ph.D., Principal investigator, Scott and White Hospital & ClinicChristine Ginocchio, Ph.D., M.T.(A.S.C.P.), Principal investigator, North Shore-LIJ Health System Laboratories, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787227
- Sponsor's protocol ID
- TDP-736-272
- Status last verified
- Mar 2016
- First submitted
- 1 Feb 2013
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (NxTAG RPP) in Patients With Clinical Signs and Symptoms of Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT01787227
- Acronym / sponsor ID
- TDP-736-272
- Conditions
- Respiratory Tract Infection, Bronchitis, Bronchiolitis, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Luminex Molecular DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- First posted
- 8 Feb 2013 (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.
xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs).
The objective of this study is to establish diagnostic accuracy of the xTAG RPP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded, Pre-selected Arm | – | Device: xTAG RPPFor targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested. |
| Blinded, Prospective Arm | – | Device: xTAG RPPDiagnostic accuracy for the more prevalent targets will be evaluated in prospectively collected, de-identified, left-over, clinical specimens accrued during the 2012/2013 flu season. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical specimens collected from patients with clinical signs and symptoms of respiratory tract infection who are either hospitalized, admitted to emergency departments or visiting outpatient clinics.
Key inclusion criteria (3 listed)
- The specimen is a nasopharyngeal swab.
- The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
- The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia.
Key exclusion criteria (2 listed)
- The specimen is not a nasopharyngeal swab.
- The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xTAG RPP | Device | Blinded, Pre-selected Arm, Blinded, Prospective Arm |
Primary outcome
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target.
Time frame: Within the first year after sample extraction
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by xTAG RPP.
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 3 Mar 2016.
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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.
Jeremy Liu, Ph.D study director
Luminex Molecular Diagnostics
James Mahony, Ph.D, FCCM, FAAM principal investigator
St. Joseph's Health Care London
Richard Buller, PhD, D (ABMM) principal investigator
St. Louis Children's Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infection and Bronchitis, run by Luminex Molecular Diagnostics at 4 sites in 2 countries.
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 3 inclusion and 2 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target. (time frame: Within the first year after sample extraction). 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 3 Mar 2016.