Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Viral Respiratory Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Respiratory Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Respiratory Symptoms

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTP0001

Identifier Type: -

Identifier Source: org_study_id