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Sample Collection Methods for Respiratory Infection Testing

N/A

Recruiting

Led By Thanh Nguyen, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing new ways to collect samples from people with respiratory infections like COVID-19, which is the 3rd leading cause of death worldwide. These new collection methods are less invasive and reduce risk to healthcare workers.

Who is the study for?

This trial is for individuals aged 19 or older who are being seen at the UNMC Emergency Department and have a non-research nasopharyngeal swab ordered. There are no other exclusion criteria, so anyone meeting the age requirement in this setting can participate.Check my eligibility

What is being tested?

The study is testing two new devices for collecting samples to diagnose respiratory infections: a nasopharyngeal wash device and a saliva collection device called the Oral Capsule. These will be compared with traditional swabbing methods to see if they're easier for patients and safer for healthcare workers.See study design

What are the potential side effects?

Since this trial involves non-invasive sample collection methods, side effects may include minor discomfort from saliva collection or finger stick blood tests. The new devices aim to reduce pain and injury risk associated with standard nasopharyngeal swabs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of respiratory pathogen infections in emergency department patients-nasophayngeal wash

Incidence rate of respiratory pathogen infections in emergency department patients -saliva drool specimen

Incidence rate of respiratory pathogen infections in emergency department patients-oral capsule saliva specimen

Secondary outcome measures

Study survey and pain rating-nasopharyngeal wash procedure

Study survey and pain rating-nose swab procedure

Study survey and pain rating-oral capsule saliva collection procedure

Trial Design

4Treatment groups

Experimental Treatment

Group I: Saliva passive droolExperimental Treatment2 Interventions

Participant is asked to spit saliva, through a straw, into a micro centrifuge tube. This specimen will undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing.

Group II: Oral Capsule salivaExperimental Treatment2 Interventions

Participant is asked to chew on a study device (Oral Capsule) with their molar teeth which will draw saliva into the device's internal specimen chamber. This specimen will undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing.

Group III: NP saline wash by study deviceExperimental Treatment2 Interventions

Participant will receive a nasopharyngeal wash with sterile saline. The irrigation saline is recollected into the device's internal specimen chamber. This specimen will undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing.

Group IV: Blood by standard finger stick methodExperimental Treatment1 Intervention

Participant is asked to provide approximately 60 uL of blood via a capillary finger stick. This specimen will undergo COVID-19 antibody testing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

COVID-19 antibody test

2021

N/A

~1500

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,143,734 Total Patients Enrolled

Thanh Nguyen, PhDPrincipal InvestigatorUniversity of Nebraska

Media Library

Oral Capsule saliva Clinical Trial Eligibility Overview. Trial Name: NCT05864118 — N/A

Respiratory Infection Research Study Groups: Oral Capsule saliva, Blood by standard finger stick method, Saliva passive drool, NP saline wash by study device

Respiratory Infection Clinical Trial 2023: Oral Capsule saliva Highlights & Side Effects. Trial Name: NCT05864118 — N/A

Oral Capsule saliva 2023 Treatment Timeline for Medical Study. Trial Name: NCT05864118 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants will the clinical trial accommodate?

"Affirmative. Clinicaltrials.gov contains evidence that this clinical trial is actively looking for participants; it was first listed on July 1st 2023 and the most recent update occurred on July 5th, 2023. The study hopes to include 1000 patients from one medical site."

Answered by AI

Has enrollment for this experiment commenced?

"Per information available on clinicaltrials.gov, this medical trial is currently in search of participants and was initially posted on July 1st 2023. The study has been amended most recently as of the 5th day of July 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Thanh Nguyen 2023. "Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05864118.