NCT01787227|Completed
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Sponsor study identifier
observational
1,500
2 countries
4
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
Not reported
Date not reportedxTAG 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2013
Actual (reported)February 8, 2013
Actual (reported)January 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 2015
Actual (reported)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.
Within the first year after sample extraction
For targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
St. Louis Children's Hospital
St Louis, Missouri, United States
North Shore-LIJ Health System Laboratories
Lake Success, New York, 11042, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6, Canada
Nasopharyngeal swab
Jeremy Liu, Ph.D
Luminex Molecular Diagnostics
James Mahony, Ph.D, FCCM, FAAM
St. Joseph's Health Care London
Richard Buller, PhD, D (ABMM)
St. Louis Children's Hospital
Arundhati Rao, M.D., Ph.D.
Scott and White Hospital & Clinic
1,500 participants (actual enrollment reported by the registry).
First Submitted
February 1, 2013
First Posted
February 8, 2013
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Diagnosing Pneumonia Under Low-resource Conditions
Contact the study team to confirm eligibility.
Christine Ginocchio, Ph.D., M.T.(A.S.C.P.)
North Shore-LIJ Health System Laboratories, NY
Primary Completion
September 2015
Actual (reported)Last Updated
March 3, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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