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
NCT number | NCT01787227 |
Other study ID # | TDP-736-272 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | February 1, 2013 |
Last updated | March 1, 2016 |
Start date | January 2015 |
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 |
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.
Status | Completed |
Enrollment | 1500 |
Est. completion date | |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Luminex Molecular Diagnostics |
United States, Canada,
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 |
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