A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787227
• Other study ID #: TDP-736-272
• Status: Completed
• Phase: N/A
• First received: February 1, 2013
• Last updated: March 1, 2016
• Start date: January 2015

Study information

• Verified date: March 2016
• Source: Luminex Molecular Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchitis
• Pneumonia
• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Device:
• xTAG RPP

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital	Hamilton	Ontario
United States	North Shore-LIJ Health System Laboratories	Lake Success	New York
United States	St. Louis Children's Hospital	St. Louis	Missouri
United States	Scott and White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Molecular Diagnostics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No