RECRUITING

Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses

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

Respiratory tract infections (RTIs) are prevalence community diseases and is the third leading cause of death worldwide. Rapid diagnosis of RTIs is essential as it drives decision points such as treatment, disposition, and containment. According to recent CDC (The Centers for Disease Control and Prevention) updates, nasopharyngeal swabbing is the preferred method of specimen collection for most RTIs such as SARS-COV-2. This process is invasive and traumatizing for patients as it requires probing (20 seconds) of the posterior nasopharynx with swab applicator. In some cases, this procedure has resulted in pain and injury. Because of the invasive nature of the procedure, patients often refuse testing or withdraw during the collection process resulting in inadequate specimen procurement. The study principle investigators (PI) have developed 2 novel specimen collection devices: 1) nasopharyngeal wash collection device (NP wash device) and 2) saliva collection device (the Oral Capsule). Both devices are designed for ease of use either by a healthcare professional or a patient. The benefits of such collection devices include 1) minimizing the invasive nature of the procedure because a swab applicator is not utilized and 2) minimizing infection risk to healthcare professional because the study devices can be self-administered when applicable. The study will enroll 1000 participants from a pool of patients presenting to the Nebraska Medicine Emergency Department (ED) who received a nasopharyngeal (NP) swab viral PCR test as part of their ED work up. Enrolled patients will be asked to provide four total specimens: 1) a saliva drool specimen, 2) a saliva Oral Capsule specimen, 3) a NP wash specimen, and 4) a finger stick serum specimen. Patients are able to opt out of any specimen collection method. Study specimens 1, 2, 3 will undergo a respiratory pathogen panel (RPP) PCR test and COVID-19 antibody testing. Study specimen 4 will undergo COVID-19 antibody testing and will function as a serum control for antibody detection.

Official Title

A Comparative Evaluation of Specimen Adequacy of a Traditional Nasopharyngeal Swab as Compared to Nasopharyngeal Saline Wash, Saliva, and Serum to Test for Respiratory Viruses and Antibody Response

Quick Facts

Study Start:2023-08-21
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05864118

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:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 19 years or older presenting to the UNMC ED, or admitted from the UNMC ED with a non-research nasopharyngeal swab ordered.
  1. * None, if the inclusion criterion is met.

Contacts and Locations

Study Contact

Thanh Nguyen, PhD
CONTACT
402-559-7884
thang.nguyen@unmc.edu
Brooklin K Zimmerman, MSN
CONTACT
402-559-5237
brooklin.zimmerman@unmc.edu

Principal Investigator

Thanh Nguyen, PhD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

Thanh Nguyen
Omaha, Nebraska, 68198-1150
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Thanh Nguyen, PhD, PRINCIPAL_INVESTIGATOR, University of Nebraska

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 Date2023-08-21
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-08-21
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Adenovirus
  • Coronavirus 229E
  • Coronavirus HKU1
  • Coronavirus NL63
  • Coronavirus OC43
  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  • Human Metapneumovirus
  • Human Rhinovirus/Enterovirus
  • Influenza A virus
  • Influenza A virus A/H1
  • Influenza A virus A/H3
  • Influenza A virus A/H1-2009
  • Influenza B virus
  • Parainfluenza virus 1
  • Parainfluenza virus 2
  • Parainfluenza virus 3
  • Parainfluenza virus 4
  • Respiratory syncytial virus
  • Bordetella parapertussis
  • Bordetella pertussis
  • Chlamydia pneumoniae
  • Mycoplasma pneumoniae

Additional Relevant MeSH Terms

  • Respiratory Tract Infections