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NCT03813966 · ClinicalTrials.gov registry record

Nasal Swab Home Collection Kit (NSHC Kit) Study

A clinical trial of Influenza Viral Infections, sponsored by University of Wisconsin, Madison.

Completed
Registry status
1,181
Enrollment target
2
Study locations

NCT03813966 is a study of Influenza Viral Infections that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 1,181 participants. The trial reports 2 study locations across 1 state.

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The verdict

NCT03813966, a study of Influenza Viral Infections, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
1,181 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal swab specimens from children, ages 0 through 12 years, and others needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the comparison of the performance of the nasal swab that is self- or parent/guardian-collected to one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia Influenza A+B FIA (fluorescence immunoassay analyzer).

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Sofia Influenza A+B FIA

Study Locations (2)

Wisconsin

  • UWHealth Urgent Care Clinics - Madison
  • UW Health Urgent Care Clinics - Madison

Trial Details

FieldValue
Enrollment Target 1,181 participants
Start Date 2019-02-07
Est. Completion 2020-06-30

Sponsor

University of Wisconsin, Madison

1,039 total trials

What the Registry Record Tells You About NCT03813966

The ClinicalTrials.gov registry entry for NCT03813966 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza Viral Infections appearing as the primary indexed condition, and to 1 intervention - of which Sofia Influenza A+B FIA is the first listed.

NCT03813966 reports 2 study locations spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT03813966 about?

NCT03813966 is a clinical study titled "Nasal Swab Home Collection Kit (NSHC Kit) Study". The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal s...

What is the current status of trial NCT03813966?

This trial is currently completed. The enrollment target is 1,181 participants. The study started on 2019-02-07. Estimated completion is 2020-06-30.

What conditions does trial NCT03813966 study?

This clinical trial studies the following conditions: Influenza Viral Infections.

What interventions are being tested in trial NCT03813966?

The interventions under investigation include: Sofia Influenza A+B FIA (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03813966?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03813966 being conducted?

This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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