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Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses
NCT05864118 · View on ClinicalTrials.gov ↗
Study Summary
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 fun
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Respiratory pathogen panel PCR test
- DIAGNOSTIC_TEST COVID-19 antibody test
Study Locations (1)
Nebraska
- Thanh Nguyen — Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-08-21 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05864118
The ClinicalTrials.gov registry entry for NCT05864118 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 272 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Tract Infections appearing as the primary indexed condition, and to 2 interventions — of which Respiratory pathogen panel PCR test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05864118 reports 1 study location spanning 1 distinct geographic area — top geographies include Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05864118 about?
NCT05864118 is a clinical study titled "Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses". 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 Pre...
What is the current status of trial NCT05864118?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2023-08-21. Estimated completion is 2026-12.
What conditions does trial NCT05864118 study?
This clinical trial studies the following conditions: Respiratory Tract Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05864118?
The interventions under investigation include: Respiratory pathogen panel PCR test (DIAGNOSTIC_TEST), COVID-19 antibody test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05864118?
This trial is sponsored by University of Nebraska, which has 272 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05864118 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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