RECRUITING

Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites

Conditions

Influenza, Human Respiratory Syncytial Virus Infections

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

Official Title

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

Quick Facts

Study Start:2020-02-06

Study Completion:2023-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04288921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The subject may be of any age and either sex. * Preliminary assessment of the subject by the Investigator/designee should be suggestive of influenza and/or RSV at the time of the study visit. The subject must exhibit two (2) or more of the following signs and symptoms for eligibility: stuffy or runny nose, sneezing, cough, sore throat, dyspnea (labored, difficult breathing), wheezing, fatigue, weakness and/or malaise, arthralgia (joint pain), myalgia (deep muscle aches), anorexia, vomiting, diarrhea, or headache. The onset of these symptoms must not have begun more than four (4) days prior to study enrollment. * The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects 18 years and older must report having a fever, but a quantitative reported measurement is not necessary for inclusion.	* The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit. * The subject is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™). * The subject is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis). * The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy. * The subject has previously participated in this research study

Inclusion Criteria

Exclusion Criteria

* The subject may be of any age and either sex.
* Preliminary assessment of the subject by the Investigator/designee should be suggestive of influenza and/or RSV at the time of the study visit. The subject must exhibit two (2) or more of the following signs and symptoms for eligibility: stuffy or runny nose, sneezing, cough, sore throat, dyspnea (labored, difficult breathing), wheezing, fatigue, weakness and/or malaise, arthralgia (joint pain), myalgia (deep muscle aches), anorexia, vomiting, diarrhea, or headache. The onset of these symptoms must not have begun more than four (4) days prior to study enrollment.
* The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects 18 years and older must report having a fever, but a quantitative reported measurement is not necessary for inclusion.

* The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
* The subject is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™).
* The subject is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
* The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
* The subject has previously participated in this research study

Contacts and Locations

Study Contact

David Craig

CONTACT

00441786533232

david.craig@lumiradx.com

Principal Investigator

Christina Ulen

PRINCIPAL_INVESTIGATOR

Advanced Pediatrics

Robert Rosen

PRINCIPAL_INVESTIGATOR

Ardmore Family Practice

Ramin Farsad

PRINCIPAL_INVESTIGATOR

Access Medical Center

Matthew Morgan

PRINCIPAL_INVESTIGATOR

Centura Health Physician Group

Jeffrey Stewart

PRINCIPAL_INVESTIGATOR

Family Medical Associates

Andre Gvozden

PRINCIPAL_INVESTIGATOR

Gvozden Pediatrics

Isaac Melamed

PRINCIPAL_INVESTIGATOR

ImmunoE Health Center

Nader Nakhleh

PRINCIPAL_INVESTIGATOR

Jersey Shore UMC

Lisa Connery

PRINCIPAL_INVESTIGATOR

Lisa Connery MD

Aftab Naz

PRINCIPAL_INVESTIGATOR

Madera Family Medical Group

Salma Elfaki

PRINCIPAL_INVESTIGATOR

Nona Pediatric Center

Adam Kaplan

PRINCIPAL_INVESTIGATOR

North Texas Family Practice

Paul Wisman

PRINCIPAL_INVESTIGATOR

Pediatric Research of Charlottesville

William Simon

PRINCIPAL_INVESTIGATOR

New Medical Healthcare

Joshua Fuller

PRINCIPAL_INVESTIGATOR

Pediatric Care

David King

PRINCIPAL_INVESTIGATOR

Southwest Care

Song Yu

PRINCIPAL_INVESTIGATOR

MedHelp Urgent Care

Michael Bell

PRINCIPAL_INVESTIGATOR

Accel-West Volusia Pediatrics

Study Locations (Sites)

MedHelp Urgent Care

Birmingham, Alabama, 35235

United States

Access Medical Center

Encinitas, California, 92024

United States

Madera Family Medical Group

Madera, California, 93637

United States

ImmunoE Health and Research

Centennial, Colorado, 80112

United States

Complete Family Care Research

Northglenn, Colorado, 80234

United States

ImmunoE Health and Research Center

Thornton, Colorado, 80233

United States

Accel-West Volusia Pediatrics

DeLand, Florida, 32720

United States

Nona Pediatric Center

Orlando, Florida, 32829

United States

New Medical

Wichita, Kansas, 67205

United States

Gvozden Pediatrics

Millersville, Maryland, 21108

United States

Kent Plaza Pediatrics

Jackson, New Jersey, 08527

United States

Jersey Shore UMC

Neptune, New Jersey, 07753

United States

Southwest Care

Santa Fe, New Mexico, 87505

United States

Ardmore Family Practice

Winston-Salem, North Carolina, 27103

United States

Lisa Connery MD

Norman, Oklahoma, 73069

United States

Family Medical Associates

Carrollton, Texas, 75010

United States

North Texas Family Practice

Plano, Texas, 75093

United States

Pediatric Care

Bountiful, Utah, 84010

United States

Pediatric Associates of Charlottesville

Charlottesville, Virginia, 22902

United States

Advanced Pediatrics

Vienna, Virginia, 22180

United States

Collaborators and Investigators

Sponsor: LumiraDx UK Limited

Christina Ulen, PRINCIPAL_INVESTIGATOR, Advanced Pediatrics
Robert Rosen, PRINCIPAL_INVESTIGATOR, Ardmore Family Practice
Ramin Farsad, PRINCIPAL_INVESTIGATOR, Access Medical Center
Matthew Morgan, PRINCIPAL_INVESTIGATOR, Centura Health Physician Group
Jeffrey Stewart, PRINCIPAL_INVESTIGATOR, Family Medical Associates
Andre Gvozden, PRINCIPAL_INVESTIGATOR, Gvozden Pediatrics
Isaac Melamed, PRINCIPAL_INVESTIGATOR, ImmunoE Health Center
Nader Nakhleh, PRINCIPAL_INVESTIGATOR, Jersey Shore UMC
Lisa Connery, PRINCIPAL_INVESTIGATOR, Lisa Connery MD
Aftab Naz, PRINCIPAL_INVESTIGATOR, Madera Family Medical Group
Salma Elfaki, PRINCIPAL_INVESTIGATOR, Nona Pediatric Center
Adam Kaplan, PRINCIPAL_INVESTIGATOR, North Texas Family Practice
Paul Wisman, PRINCIPAL_INVESTIGATOR, Pediatric Research of Charlottesville
William Simon, PRINCIPAL_INVESTIGATOR, New Medical Healthcare
Joshua Fuller, PRINCIPAL_INVESTIGATOR, Pediatric Care
David King, PRINCIPAL_INVESTIGATOR, Southwest Care
Song Yu, PRINCIPAL_INVESTIGATOR, MedHelp Urgent Care
Michael Bell, PRINCIPAL_INVESTIGATOR, Accel-West Volusia Pediatrics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-06

Study Completion Date2023-09-30

Study Record Updates

Study Start Date2020-02-06

Study Completion Date2023-09-30

Terms related to this study

Additional Relevant MeSH Terms

Influenza, Human
Respiratory Syncytial Virus Infections