InfluenzaPhase 4NCT04141917
Test-and-treat for Influenza in Homeless Shelters
A Phase 4 study testing Point-of-care molecular testing and treatment of influenza in people with Influenza and Respiratory Viral Infection, run by University of Washington at 9 sites in United States.
Trial summary
This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment for influenza in homeless shelters within the Seattle area to determine whether this strategy reduced the incidence of influenza in the shelter environment. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Influenza, Respiratory Viral Infection
- What is being tested?
- Point-of-care molecular testing and treatment of influenza
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,618 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Nov 2019to 31 Mar 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resident for 1 or more days at a participating shelter
- ≥2 ARI symptoms or acute cough alone
- Willing to take study medication
- Willing to comply with all study procedures, including weekly surveillance and repeat nasal swab at day 2/3 and day 5/6/7 post-treatment
- Able to provide written, informed consent and/or assent
Who cannot join
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
- Inability to consent and/or comply with study protocol
- Individuals who have received oseltamivir or baloxavir within past 7 days for treatment of influenza
- Individuals with known hypersensitivity to baloxavir marboxil or oseltamivir
- Individuals with chronic kidney disease
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Mary's Place Burien
Burien, Washington, 98146
Compass Housing Alliance at First Presbyterian
Seattle, Washington, 98104
Downtown Emergency Service Center Shelter
Seattle, Washington, 98104
ROOTS Young Adult Shelter
Seattle, Washington, 98105
Compass Housing Alliance Blaine Center Men's Shelter
Seattle, Washington, 98109
Mary's Place North Seattle
Seattle, Washington, 98133
St Martin De Porres Shelter
Seattle, Washington, 98134
Compass Housing Alliance Jan & Peter's Place Women's Shelter
Seattle, Washington, 98144
Mary's Place White Center
Seattle, Washington, 98146
About this study
Official title: Stepped-wedge Design Study of Point-of-care Molecular Testing for Influenza and Treatment With Baloxavir for Prevention of Secondary Transmission of Influenza in Homeless Shelters in Seattle, WA
This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment for influenza in homeless shelters within the Seattle area to determine whether this strategy reduced the incidence of influenza in the shelter environment.
Read the detailed description
The study will be conducted over the course of two flu seasons, and all shelters will start with routine surveillance of influenza using mid-turbinate nasal swabs for sample collection and RT-PCR testing. Shelters will be randomized to implement a test-and-treat strategy at different months throughout flu season, treating individuals who present ARI symptoms or new or worsening cough within 2 days (48 hours). Shelters will continue routine surveillance until all offer the test-and-treat strategy. Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment. Individuals with 3-7 days of symptoms, or who choose not to participate in the intervention strategy, will still be eligible for participation in the routine surveillance.
Our primary hypothesis is that implementation of a point-of-care diagnostic and antiviral treatment intervention among sheltered individuals experiencing homelessness will reduce the incidence of influenza within this population over the course of a flu season. A process evaluation will also be conducted to explore the feasibility of point-of-care testing implementation in this population.
- Conditions
- Influenza, Respiratory Viral Infection
- Being tested
- Point-of-care molecular testing and treatment of influenza
- Keywords
- Tamiflu, Oseltamivir, Baloxavir, Influenza, Flu, Rapid Test, Xofluza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care molecular testing and treatment of influenzaCombination product
Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving.
| Study group | Role | What they receive |
|---|---|---|
| Standard influenza surveillance | No intervention | Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing. |
| Point-of-care molecular testing and treatment of influenza | Active comparator | Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A \& B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) . Receives: Combination Product: Point-of-care molecular testing and treatment of influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period
The intervention period is when test and treatment on-site was available and the control period is when just standard surveillance was available at a shelter.
Measured: Year 1 of the intervention (4.5 months)
Secondary outcomes (7)
Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters
Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR.
Measured: Up to 24 months
Feasibility of Implementation of Influenza Treatment in Shelters
Number of influenza-positive participants identified through on-site molecular testing in the intervention period that were treated with an antiviral
Measured: Up to 24 months
Number of Participants That Drop Out of Study
Measured as becoming lost to follow-up (did not complete both follow-up study visits on day 2/3 and day 5/6/7) after testing positive for influenza at baseline enrollment with an on-site molecular test and receiving an antiviral
Measured: Up to 24 months
Number of Participants That Show Non-compliance With Study Drug
Only applicable to those that receive oseltamivir rather than baloxavir which is a single-dose antiviral. Measured based on self-report during follow-up visits with study research assistants. Non-compliance is measured as the participant self-reporting fewer doses taken than to be expected at time of of follow-up (e.g. a participant that took there first dose of oseltamivir in the AM on March 8 would be expected to have taken 6 doses if their follow-up visit was in the PM on March 10).
Measured: Up to 24 months
Number of Laboratory-confirmed Influenza Cases That Report Fever
Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement
Measured: Up to 24 months
Influenza Viral RNA Levels
Measured mean cycle threshold (Ct) value for each laboratory-confirmed influenza-positive specimen collected at baseline enrollment, by subtype. Ct values have an inverse relationship with viral load.
Measured: Up to 24 months
Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7
Measured at subject follow-up visits with nasal swabs provided to study staff; provided subject has not become lost to follow up.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start15 Nov 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Why it stopped: Operational futility (i.e. near zero circulation of influenza in the community during year 2)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Helen Chu, University of Washington
- Investigators
- Helen Y Chu, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141917
- Sponsor's protocol ID
- STUDY00007800
- Status last verified
- May 2022
- First submitted
- 23 Oct 2019
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions. All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing.
Publications
Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.
PubMed 30184455Boonyaratanakornkit J, Ekici S, Magaret A, Gustafson K, Scott E, Haglund M, Kuypers J, Pergamit R, Lynch J, Chu HY. Respiratory Syncytial Virus Infection in Homeless Populations, Washington, USA. Emerg Infect Dis. 2019 Jul;25(7):1408-1411. doi: 10.3201/eid2507.181261.
PubMed 31211675Hwang SW, Orav EJ, O'Connell JJ, Lebow JM, Brennan TA. Causes of death in homeless adults in Boston. Ann Intern Med. 1997 Apr 15;126(8):625-8. doi: 10.7326/0003-4819-126-8-199704150-00007.
PubMed 9103130Thiberville SD, Salez N, Benkouiten S, Badiaga S, Charrel R, Brouqui P. Respiratory viruses within homeless shelters in Marseille, France. BMC Res Notes. 2014 Feb 5;7:81. doi: 10.1186/1756-0500-7-81.
PubMed 24499605Cox SN, Rogers JH, Thuo NB, Meehan A, Link AC, Lo NK, Manns BJ, Chow EJ, Al Achkar M, Hughes JP, Rolfes MA, Mosites E, Chu HY. Trends and factors associated with change in COVID-19 vaccination intent among residents and staff in six Seattle homeless shelters, March 2020 to August 2021. Vaccine X. 2022 Dec;12:100232. doi: 10.1016/j.jvacx.2022.100232. Epub 2022 Oct 19.
PubMed 36276877Chow EJ, Casto AM, Roychoudhury P, Han PD, Xie H, Pfau B, Nguyen TV, Sereewit J, Rogers JH, Cox SN, Wolf CR, Rolfes MA, Mosites E, Uyeki TM, Greninger AL, Hughes JP, Shim MM, Sugg N, Duchin JS, Starita LM, Englund JA, Chu HY. The Clinical and Genomic Epidemiology of Rhinovirus in Homeless Shelters-King County, Washington. J Infect Dis. 2022 Oct 7;226(Suppl 3):S304-S314. doi: 10.1093/infdis/jiac239.
PubMed 35749582Rogers JH, Cox SN, Hughes JP, Link AC, Chow EJ, Fosse I, Lukoff M, Shim MM, Uyeki TM, Ogokeh C, Jackson ML, Boeckh M, Englund JA, Mosites E, Rolfes MA, Chu HY. Trends in COVID-19 vaccination intent and factors associated with deliberation and reluctance among adult homeless shelter residents and staff, 1 November 2020 to 28 February 2021 - King County, Washington. Vaccine. 2022 Jan 3;40(1):122-132. doi: 10.1016/j.vaccine.2021.11.026. Epub 2021 Nov 15.
PubMed 34863618Newman KL, Rogers JH, McCulloch D, Wilcox N, Englund JA, Boeckh M, Uyeki TM, Jackson ML, Starita L, Hughes JP, Chu HY; Seattle Flu Study Investigators. Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial. Trials. 2020 Nov 23;21(1):956. doi: 10.1186/s13063-020-04871-5.
PubMed 33228787Rogers JH, Link AC, McCulloch D, Brandstetter E, Newman KL, Jackson ML, Hughes JP, Englund JA, Boeckh M, Sugg N, Ilcisin M, Sibley TR, Fay K, Lee J, Han P, Truong M, Richardson M, Nickerson DA, Starita LM, Bedford T, Chu HY; Seattle Flu Study Investigators. Characteristics of COVID-19 in Homeless Shelters : A Community-Based Surveillance Study. Ann Intern Med. 2021 Jan;174(1):42-49. doi: 10.7326/M20-3799. Epub 2020 Sep 15.
PubMed 32931328
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped-wedge Design Study of Point-of-care Molecular Testing for Influenza and Treatment With Baloxavir for Prevention of Secondary Transmission of Influenza in Homeless Shelters in Seattle, WA
- ClinicalTrials.gov ID
- NCT04141917
- Acronym / sponsor ID
- STUDY00007800
- Conditions
- Influenza, Respiratory Viral Infection
- Keywords
- Tamiflu, Oseltamivir, Baloxavir, Influenza, Flu, Rapid Test, Xofluza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Operational futility (i.e. near zero circulation of influenza in the community during year 2)
- Enrolment
- 1,618 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Posted 22 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment for influenza in homeless shelters within the Seattle area to determine whether this strategy reduced the incidence of influenza in the shelter environment.
Detailed description
The study will be conducted over the course of two flu seasons, and all shelters will start with routine surveillance of influenza using mid-turbinate nasal swabs for sample collection and RT-PCR testing. Shelters will be randomized to implement a test-and-treat strategy at different months throughout flu season, treating individuals who present ARI symptoms or new or worsening cough within 2 days (48 hours). Shelters will continue routine surveillance until all offer the test-and-treat strategy. Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment. Individuals with 3-7 days of symptoms, or who choose not to participate in the intervention strategy, will still be eligible for participation in the routine surveillance.
Our primary hypothesis is that implementation of a point-of-care diagnostic and antiviral treatment intervention among sheltered individuals experiencing homelessness will reduce the incidence of influenza within this population over the course of a flu season. A process evaluation will also be conducted to explore the feasibility of point-of-care testing implementation in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard influenza surveillance | No intervention | –Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing. |
| Point-of-care molecular testing and treatment of influenza | Active comparator | Combination Product: Point-of-care molecular testing and treatment of influenzaSubjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A \& B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) . |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Resident for 1 or more days at a participating shelter
- ≥2 ARI symptoms or acute cough alone
- Willing to take study medication
- Willing to comply with all study procedures, including weekly surveillance and repeat nasal swab at day 2/3 and day 5/6/7 post-treatment
- Able to provide written, informed consent and/or assent
Key exclusion criteria (5 listed)
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
- Inability to consent and/or comply with study protocol
- Individuals who have received oseltamivir or baloxavir within past 7 days for treatment of influenza
- Individuals with known hypersensitivity to baloxavir marboxil or oseltamivir
- Individuals with chronic kidney disease
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 |
|---|---|---|
| Point-of-care molecular testing and treatment of influenzaEligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving. | Combination product | Point-of-care molecular testing and treatment of influenza |
Primary outcome
Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period
Time frame: Year 1 of the intervention (4.5 months)
The intervention period is when test and treatment on-site was available and the control period is when just standard surveillance was available at a shelter.
7 secondary outcomes
Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters
Time frame: Up to 24 months
Feasibility of Implementation of Influenza Treatment in Shelters
Time frame: Up to 24 months
Number of Participants That Drop Out of Study
Time frame: Up to 24 months
Number of Participants That Show Non-compliance With Study Drug
Time frame: Up to 24 months
Number of Laboratory-confirmed Influenza Cases That Report Fever
Time frame: Up to 24 months
Influenza Viral RNA Levels
Time frame: Up to 24 months
Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30184455Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.
- Background: PubMed 31211675Boonyaratanakornkit J, Ekici S, Magaret A, Gustafson K, Scott E, Haglund M, Kuypers J, Pergamit R, Lynch J, Chu HY. Respiratory Syncytial Virus Infection in Homeless Populations, Washington, USA. Emerg Infect Dis. 2019 Jul;25(7):1408-1411. doi: 10.3201/eid2507.181261.
- Background: PubMed 9103130Hwang SW, Orav EJ, O'Connell JJ, Lebow JM, Brennan TA. Causes of death in homeless adults in Boston. Ann Intern Med. 1997 Apr 15;126(8):625-8. doi: 10.7326/0003-4819-126-8-199704150-00007.
- Background: PubMed 24499605Thiberville SD, Salez N, Benkouiten S, Badiaga S, Charrel R, Brouqui P. Respiratory viruses within homeless shelters in Marseille, France. BMC Res Notes. 2014 Feb 5;7:81. doi: 10.1186/1756-0500-7-81.
- Derived from this study: PubMed 36276877Cox SN, Rogers JH, Thuo NB, Meehan A, Link AC, Lo NK, Manns BJ, Chow EJ, Al Achkar M, Hughes JP, Rolfes MA, Mosites E, Chu HY. Trends and factors associated with change in COVID-19 vaccination intent among residents and staff in six Seattle homeless shelters, March 2020 to August 2021. Vaccine X. 2022 Dec;12:100232. doi: 10.1016/j.jvacx.2022.100232. Epub 2022 Oct 19.
- Derived from this study: PubMed 35749582Chow EJ, Casto AM, Roychoudhury P, Han PD, Xie H, Pfau B, Nguyen TV, Sereewit J, Rogers JH, Cox SN, Wolf CR, Rolfes MA, Mosites E, Uyeki TM, Greninger AL, Hughes JP, Shim MM, Sugg N, Duchin JS, Starita LM, Englund JA, Chu HY. The Clinical and Genomic Epidemiology of Rhinovirus in Homeless Shelters-King County, Washington. J Infect Dis. 2022 Oct 7;226(Suppl 3):S304-S314. doi: 10.1093/infdis/jiac239.
- Derived from this study: PubMed 34863618Rogers JH, Cox SN, Hughes JP, Link AC, Chow EJ, Fosse I, Lukoff M, Shim MM, Uyeki TM, Ogokeh C, Jackson ML, Boeckh M, Englund JA, Mosites E, Rolfes MA, Chu HY. Trends in COVID-19 vaccination intent and factors associated with deliberation and reluctance among adult homeless shelter residents and staff, 1 November 2020 to 28 February 2021 - King County, Washington. Vaccine. 2022 Jan 3;40(1):122-132. doi: 10.1016/j.vaccine.2021.11.026. Epub 2021 Nov 15.
- Derived from this study: PubMed 33228787Newman KL, Rogers JH, McCulloch D, Wilcox N, Englund JA, Boeckh M, Uyeki TM, Jackson ML, Starita L, Hughes JP, Chu HY; Seattle Flu Study Investigators. Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial. Trials. 2020 Nov 23;21(1):956. doi: 10.1186/s13063-020-04871-5.
- Derived from this study: PubMed 32931328Rogers JH, Link AC, McCulloch D, Brandstetter E, Newman KL, Jackson ML, Hughes JP, Englund JA, Boeckh M, Sugg N, Ilcisin M, Sibley TR, Fay K, Lee J, Han P, Truong M, Richardson M, Nickerson DA, Starita LM, Bedford T, Chu HY; Seattle Flu Study Investigators. Characteristics of COVID-19 in Homeless Shelters : A Community-Based Surveillance Study. Ann Intern Med. 2021 Jan;174(1):42-49. doi: 10.7326/M20-3799. Epub 2020 Sep 15.
- Individual participant dataSharing planned: No. We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions. All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing.
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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.
Helen Y Chu, MD, MPH principal investigator
University of Washington
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Point-of-care molecular testing and treatment of influenza in people with Influenza and Respiratory Viral Infection, run by University of Washington at 9 sites 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period (time frame: Year 1 of the intervention (4.5 months)). 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 NCT04141917, which also lists 9 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 22 Jun 2022.