Respiratory Tract InfectionsNCT05864118
Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses
A study testing Respiratory pathogen panel PCR test and COVID-19 antibody test in people with Respiratory Tract Infections, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Respiratory pathogen panel PCR test and COVID-19 antibody test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older presenting to the UNMC ED, or admitted from the UNMC ED with a non-research nasopharyngeal swab ordered.
Who cannot join
- None, if the inclusion criterion is met.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Respiratory tract infections (RTIs) are high prevalence community diseases and is the third leading cause of death worldwide. It is estimated that a new infectious disease emerges at a rate of one per year, making early disease detection critically important. Within the past few decades, we have seen an increase in cases of novel respiratory illnesses such as SARS (severe acute respiratory syndrome), H1N1 (Swine Influenza), MERS (Middle East respiratory syndrome), and SARS-COV-2 (severe acute respiratory syndrome coronavirus 2). Rapid diagnosis of RTIs is essential to the management of patients experiencing respiratory symptoms as it drives decision points such as treatment and disposition. There are currently millions of confirmed SARS-COV-2 cases globally. This number is likely underreported given the limitations and barriers to confirmatory testing. This problem is compounded by other RTIs such as influenza and rhinovirus, which are also tested via a nasopharyngeal swab specimen. According to recent updates from the CDC, nasopharyngeal swabbing is the preferred method of specimen collection for SARS-COV-2. The nasopharyngeal swab method is also commonly used in the testing of other viral pathogens such as influenza, respiratory syncytial virus (RSV), rhinovirus, and human parainfluenza. This process can be somewhat invasive and traumatizing for patients as it requires probing (10-20 seconds) of the posterior nasopharynx with a stiff swab applicator. In some cases, this procedure has been known to result 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. In our effort to streamline the specimen collection process, our team has developed working prototypes of two specimen devices (a NP wash collection device and an Oral Capsule saliva collection device).
- The NP wash device is designed to irrigate the patient's nasopharyngeal passage with 3 ml of sterile saline and recollect the solution for testing. In our preliminary testing, the study device was successful in collecting RNase P from the nasal passages 100% of the time while achieving a mean Cycle Threshold (CT) value of 29.5. Participants in early studies also reported the study device to be more comfortable (0.3/10 pain) than the nasopharyngeal swab (8/10 pain).
- The Oral Capsule device is a soft-hollow device that is inserted into the mouth, overlying their molars. As the patient bites on the device, it generates an intermittent suction force which pulls saliva into the device's specimen chamber. In preliminary testing, the saliva collection device was successful in consistently collecting approximately 1 ml of saliva with 5-10 seconds of use.
The study design of this new protocol will allow the study investigators calculate the study devices' sensitivity and specificity for pathogen testing and test for antibody response from each respective specimen, along with improving enrollment rates. This study will enroll up to 1000 participants from a pool of ED patients who received a nasopharyngeal swab for PCR testing as part of their standard work up. Enrolled patients will provide four specimens 1) saliva drool specimen, 2) Oral Capsule saliva specimen, 3) NP wash specimen, and 4) finger stick serum specimen. Specimens 1, 2, 3 will undergo RPP PCR testing and COVID-19 antibody testing. Specimen 4 will undergo COVID-19 antibody testing. Patients can opt out of any of the four study specimen collection processes. Manufacturing of the NP Wash and the Oral Capsule devices is handled by the UNMC Department of Emergency Medicine fabrication lab. The NP wash study device is manufactured using fused deposition modeling (FDM) 3D printing technology with polylactic acid (PLA) printing material. The Oral Capsule device is manufactured using FDM 3D printing technology with polypropylene printing material. All study device will be sterilized via a cidex rinse, allowed to dry, then stored in a specimen bag. The NP wash device is designed to irrigate the user's nasopharyngeal cavity with 3 ml of sterile saline and recapture the irrigation solution into a specimen chamber as it drains back from their nose. The Oral Capsule device is designed to collect saliva via intermittent suction force generated within the device as the patient repeatedly bite on the device. With the implementation of our study devices we anticipate the following potential paradigm shifts in testing procedures: 1) minimizing the invasive nature of the procedure as a swab applicator is not utilized and 2) the procedure can be performed by a healthcare professional or solely by the patient, minimizing the risk of cross-infection to the healthcare professional. Nasopharyngeal irrigation is a common home remedy (neti-pots/bottles) for cold symptoms and is generally well tolerated by the user.
- Conditions
- Respiratory Tract Infections
- Being tested
- Respiratory pathogen panel PCR test, COVID-19 antibody test
- Keywords
- 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
- Medical subject headings
- Respiratory Tract Infections, Adenoviridae Infections, Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory pathogen panel PCR testDiagnostic test
Respiratory pathogen panel PCR test and COVID-19 antibody test.
COVID-19 antibody testDiagnostic test
COVID-19 antibody test
| Study group | Role | What they receive |
|---|---|---|
| Saliva passive drool | Experimental | 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. Receives: Diagnostic Test: Respiratory pathogen panel PCR test; Diagnostic Test: COVID-19 antibody test |
| Oral Capsule saliva | Experimental | 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. Receives: Diagnostic Test: Respiratory pathogen panel PCR test; Diagnostic Test: COVID-19 antibody test |
| NP saline wash by study device | Experimental | 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. Receives: Diagnostic Test: Respiratory pathogen panel PCR test; Diagnostic Test: COVID-19 antibody test |
| Blood by standard finger stick method | Experimental | Participant is asked to provide approximately 60 uL of blood via a capillary finger stick. This specimen will undergo COVID-19 antibody testing. Receives: Diagnostic Test: COVID-19 antibody test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory pathogen infections in emergency department patients-nasophayngeal wash
Determine the incidence rate of respiratory pathogen infections in emergency department patients using a nasopharyngeal wash specimen by means of a polymerase chain reaction (PCR).
Measured: 1 year
Incidence rate of respiratory pathogen infections in emergency department patients -saliva drool specimen
Determine the incidence rate of respiratory pathogen infections in emergency department patients using a saliva drool specimen by means of a polymerase chain reaction (PCR).
Measured: 1 year
Incidence rate of respiratory pathogen infections in emergency department patients-oral capsule saliva specimen
Determine the incidence rate of respiratory pathogen infections in emergency department patients using an oral capsule saliva specimen by means of a polymerase chain reaction (PCR).
Measured: 1 year
Secondary outcomes (3)
Study survey and pain rating-nose swab procedure
Patient will be asked to complete a study survey and provide a pain rating of the nose swab procedure using a 0-10 pain scale (0 = no discomfort to 10 = a lot of discomfort).
Measured: 1 year
Study survey and pain rating-nasopharyngeal wash procedure
Patient will be asked to complete a study survey and provide a pain rating of the nasopharyngeal wash procedure using a 0-10 (0 = no discomfort to 10 = a lot of discomfort).
Measured: 1 year
Study survey and pain rating-oral capsule saliva collection procedure
Patient will be asked to complete a study survey and provide a pain rating of the oral capsule saliva collection procedure using a 0-10 pain scale (0 = no discomfort to 10 = a lot of discomfort).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start21 Aug 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Adult emergency department patients receiving nasopharyngeal swab for respiratory viral testing meet inclusion criteria and will be asked to provide up to 4 study specimens.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thanh Nguyen, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864118
- Sponsor's protocol ID
- 0777-22-EP
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brendish NJ, Malachira AK, Armstrong L, Houghton R, Aitken S, Nyimbili E, Ewings S, Lillie PJ, Clark TW. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet Respir Med. 2017 May;5(5):401-411. doi: 10.1016/S2213-2600(17)30120-0. Epub 2017 Apr 6.
PubMed 28392237Zumla A, Al-Tawfiq JA, Enne VI, Kidd M, Drosten C, Breuer J, Muller MA, Hui D, Maeurer M, Bates M, Mwaba P, Al-Hakeem R, Gray G, Gautret P, Al-Rabeeah AA, Memish ZA, Gant V. Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections--needs, advances, and future prospects. Lancet Infect Dis. 2014 Nov;14(11):1123-1135. doi: 10.1016/S1473-3099(14)70827-8. Epub 2014 Sep 1.
PubMed 25189349Abad, X. Biocontainment in low income countries: a short discussion. Medical Safety & Global Health. 2018. 7(1), 1-3. DOI: 10.4172/2574-0407/1000139.
Interim guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus disease 2019 (COVID-19). Center for Disease Control and Prevention. 2020. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html.
Daley P, Castriciano S, Chernesky M, Smieja M. Comparison of flocked and rayon swabs for collection of respiratory epithelial cells from uninfected volunteers and symptomatic patients. J Clin Microbiol. 2006 Jun;44(6):2265-7. doi: 10.1128/JCM.02055-05.
PubMed 16757636Fry DE. Pressure Irrigation of Surgical Incisions and Traumatic Wounds. Surg Infect (Larchmt). 2017 May/Jun;18(4):424-430. doi: 10.1089/sur.2016.252. Epub 2017 Mar 1.
PubMed 28437197Ball, S. Optimal pressures and irrigation techniques in small-animal wound management. Veterinary Nursing Journal. 2017. 32(11). 325-328.
Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014 May;42(5):525-9. doi: 10.1016/j.ajic.2014.01.012.
PubMed 24773788
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05864118
- Acronym / sponsor ID
- 0777-22-EP
- Conditions
- Respiratory Tract Infections
- Keywords
- Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Human Metapneumovirus, Human Rhinovirus/Enterovirus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Respiratory tract infections (RTIs) are high prevalence community diseases and is the third leading cause of death worldwide. It is estimated that a new infectious disease emerges at a rate of one per year, making early disease detection critically important. Within the past few decades, we have seen an increase in cases of novel respiratory illnesses such as SARS (severe acute respiratory syndrome), H1N1 (Swine Influenza), MERS (Middle East respiratory syndrome), and SARS-COV-2 (severe acute respiratory syndrome coronavirus 2). Rapid diagnosis of RTIs is essential to the management of patients experiencing respiratory symptoms as it drives decision points such as treatment and disposition. There are currently millions of confirmed SARS-COV-2 cases globally. This number is likely underreported given the limitations and barriers to confirmatory testing. This problem is compounded by other RTIs such as influenza and rhinovirus, which are also tested via a nasopharyngeal swab specimen. According to recent updates from the CDC, nasopharyngeal swabbing is the preferred method of specimen collection for SARS-COV-2. The nasopharyngeal swab method is also commonly used in the testing of other viral pathogens such as influenza, respiratory syncytial virus (RSV), rhinovirus, and human parainfluenza. This process can be somewhat invasive and traumatizing for patients as it requires probing (10-20 seconds) of the posterior nasopharynx with a stiff swab applicator. In some cases, this procedure has been known to result 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. In our effort to streamline the specimen collection process, our team has developed working prototypes of two specimen devices (a NP wash collection device and an Oral Capsule saliva collection device).
- The NP wash device is designed to irrigate the patient's nasopharyngeal passage with 3 ml of sterile saline and recollect the solution for testing. In our preliminary testing, the study device was successful in collecting RNase P from the nasal passages 100% of the time while achieving a mean Cycle Threshold (CT) value of 29.5. Participants in early studies also reported the study device to be more comfortable (0.3/10 pain) than the nasopharyngeal swab (8/10 pain).
- The Oral Capsule device is a soft-hollow device that is inserted into the mouth, overlying their molars. As the patient bites on the device, it generates an intermittent suction force which pulls saliva into the device's specimen chamber. In preliminary testing, the saliva collection device was successful in consistently collecting approximately 1 ml of saliva with 5-10 seconds of use.
The study design of this new protocol will allow the study investigators calculate the study devices' sensitivity and specificity for pathogen testing and test for antibody response from each respective specimen, along with improving enrollment rates. This study will enroll up to 1000 participants from a pool of ED patients who received a nasopharyngeal swab for PCR testing as part of their standard work up. Enrolled patients will provide four specimens 1) saliva drool specimen, 2) Oral Capsule saliva specimen, 3) NP wash specimen, and 4) finger stick serum specimen. Specimens 1, 2, 3 will undergo RPP PCR testing and COVID-19 antibody testing. Specimen 4 will undergo COVID-19 antibody testing. Patients can opt out of any of the four study specimen collection processes. Manufacturing of the NP Wash and the Oral Capsule devices is handled by the UNMC Department of Emergency Medicine fabrication lab. The NP wash study device is manufactured using fused deposition modeling (FDM) 3D printing technology with polylactic acid (PLA) printing material. The Oral Capsule device is manufactured using FDM 3D printing technology with polypropylene printing material. All study device will be sterilized via a cidex rinse, allowed to dry, then stored in a specimen bag. The NP wash device is designed to irrigate the user's nasopharyngeal cavity with 3 ml of sterile saline and recapture the irrigation solution into a specimen chamber as it drains back from their nose. The Oral Capsule device is designed to collect saliva via intermittent suction force generated within the device as the patient repeatedly bite on the device. With the implementation of our study devices we anticipate the following potential paradigm shifts in testing procedures: 1) minimizing the invasive nature of the procedure as a swab applicator is not utilized and 2) the procedure can be performed by a healthcare professional or solely by the patient, minimizing the risk of cross-infection to the healthcare professional. Nasopharyngeal irrigation is a common home remedy (neti-pots/bottles) for cold symptoms and is generally well tolerated by the user.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Adult emergency department patients receiving nasopharyngeal swab for respiratory viral testing meet inclusion criteria and will be asked to provide up to 4 study specimens.
| Arm | Type | Receives |
|---|---|---|
| Saliva passive drool | Experimental | Diagnostic Test: Respiratory pathogen panel PCR test, Diagnostic Test: COVID-19 antibody testParticipant 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. |
| Oral Capsule saliva | Experimental | Diagnostic Test: Respiratory pathogen panel PCR test, Diagnostic Test: COVID-19 antibody testParticipant 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. |
| NP saline wash by study device | Experimental | Diagnostic Test: Respiratory pathogen panel PCR test, Diagnostic Test: COVID-19 antibody testParticipant 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. |
| Blood by standard finger stick method | Experimental | Diagnostic Test: COVID-19 antibody testParticipant is asked to provide approximately 60 uL of blood via a capillary finger stick. This specimen will undergo COVID-19 antibody testing. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19 years or older presenting to the UNMC ED, or admitted from the UNMC ED with a non-research nasopharyngeal swab ordered.
Key exclusion criteria (1 listed)
- None, if the inclusion criterion is met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory pathogen panel PCR testRespiratory pathogen panel PCR test and COVID-19 antibody test. | Diagnostic test | NP saline wash by study device, Oral Capsule saliva, Saliva passive drool |
| COVID-19 antibody testCOVID-19 antibody test | Diagnostic test | Blood by standard finger stick method, NP saline wash by study device, Oral Capsule saliva, Saliva passive drool |
Primary outcome
Incidence of respiratory pathogen infections in emergency department patients-nasophayngeal wash
Time frame: 1 year
Determine the incidence rate of respiratory pathogen infections in emergency department patients using a nasopharyngeal wash specimen by means of a polymerase chain reaction (PCR).
Incidence rate of respiratory pathogen infections in emergency department patients -saliva drool specimen
Time frame: 1 year
Determine the incidence rate of respiratory pathogen infections in emergency department patients using a saliva drool specimen by means of a polymerase chain reaction (PCR).
Incidence rate of respiratory pathogen infections in emergency department patients-oral capsule saliva specimen
Time frame: 1 year
Determine the incidence rate of respiratory pathogen infections in emergency department patients using an oral capsule saliva specimen by means of a polymerase chain reaction (PCR).
3 secondary outcomes
Study survey and pain rating-nose swab procedure
Time frame: 1 year
Study survey and pain rating-nasopharyngeal wash procedure
Time frame: 1 year
Study survey and pain rating-oral capsule saliva collection procedure
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 28392237Brendish NJ, Malachira AK, Armstrong L, Houghton R, Aitken S, Nyimbili E, Ewings S, Lillie PJ, Clark TW. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet Respir Med. 2017 May;5(5):401-411. doi: 10.1016/S2213-2600(17)30120-0. Epub 2017 Apr 6.
- Background: PubMed 25189349Zumla A, Al-Tawfiq JA, Enne VI, Kidd M, Drosten C, Breuer J, Muller MA, Hui D, Maeurer M, Bates M, Mwaba P, Al-Hakeem R, Gray G, Gautret P, Al-Rabeeah AA, Memish ZA, Gant V. Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections--needs, advances, and future prospects. Lancet Infect Dis. 2014 Nov;14(11):1123-1135. doi: 10.1016/S1473-3099(14)70827-8. Epub 2014 Sep 1.
- BackgroundAbad, X. Biocontainment in low income countries: a short discussion. Medical Safety & Global Health. 2018. 7(1), 1-3. DOI: 10.4172/2574-0407/1000139.
- BackgroundInterim guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus disease 2019 (COVID-19). Center for Disease Control and Prevention. 2020. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html.
- Background: PubMed 16757636Daley P, Castriciano S, Chernesky M, Smieja M. Comparison of flocked and rayon swabs for collection of respiratory epithelial cells from uninfected volunteers and symptomatic patients. J Clin Microbiol. 2006 Jun;44(6):2265-7. doi: 10.1128/JCM.02055-05.
- Background: PubMed 28437197Fry DE. Pressure Irrigation of Surgical Incisions and Traumatic Wounds. Surg Infect (Larchmt). 2017 May/Jun;18(4):424-430. doi: 10.1089/sur.2016.252. Epub 2017 Mar 1.
- BackgroundBall, S. Optimal pressures and irrigation techniques in small-animal wound management. Veterinary Nursing Journal. 2017. 32(11). 325-328.
- Background: PubMed 24773788Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014 May;42(5):525-9. doi: 10.1016/j.ajic.2014.01.012.
- Individual participant dataSharing planned: No
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanh Nguyen, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory pathogen panel PCR test and COVID-19 antibody test in people with Respiratory Tract Infections, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory pathogen infections in emergency department patients-nasophayngeal wash (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05864118, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.