NCT01787227

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

February 1, 2013

Last Update Submit

March 1, 2016

Conditions

Respiratory Tract InfectionBronchitisBronchiolitisPneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

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.

Device: xTAG RPP

Interventions

xTAG RPPDEVICE
Blinded, Pre-selected ArmBlinded, Prospective Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St. Louis Children's Hospital

St Louis, Missouri, United States

Location

North Shore-LIJ Health System Laboratories

Lake Success, New York, 11042, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab

MeSH Terms

Conditions

Respiratory Tract InfectionsBronchitisBronchiolitisPneumonia

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Jeremy Liu, Ph.D

    Luminex Molecular Diagnostics

    STUDY DIRECTOR

  • James Mahony, Ph.D, FCCM, FAAM

    St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

  • Richard Buller, PhD, D (ABMM)

    St. Louis Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Arundhati Rao, M.D., Ph.D.

    Scott and White Hospital & Clinic

    PRINCIPAL INVESTIGATOR

  • Christine Ginocchio, Ph.D., M.T.(A.S.C.P.)

    North Shore-LIJ Health System Laboratories, NY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 8, 2013

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(3)CA(1)