InfluenzaNCT06207058
Evaluation of a Screen and Treat Protocol for Influenza
An observational study of Influenza, run by Tricore, Inc at 1 site in United States.
Trial summary
This study seeks to demonstrate that the laboratory can mitigate respiratory virus transmission in underserved populations by using laboratory data to identify communities at risk for increase vial activity (hot spots) and intervening with a test-to-treat model provides increased access to influenza diagnostics and… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Baloxavir Marboxil
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 1 Jul 2024
- Phase
- Observational
- 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 5 years and older
- All sexes
- Child, Adult, Older adult
Study population: Individuals in respiratory hot spots and socially vulnerable communities identified in the algorithm.
Who may be able to join
- Adult patients: Signed informed consent by any patient capable of giving consent, or, where the patient is not capable of giving consent, by his or her legal/authorized representative.
- Adolescent patients not able to legally consent: written informed consent for study participation is obtained from patient's parents or legal guardian, with assent as appropriate by the patient, depending on the patient's level of understanding and capability to provide assent
- Age ³ 5 years at the time of signing the Informed Consent Form/Assent Form
- Ability to comply with the study protocol, in the investigator's judgment.
- Presence of (a) fever (≥38.0 °C per tympanic or rectal thermometer; ≥37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
- The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.
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- For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse):
- Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 28 days after the last dose of study treatment. Hormonal contraceptive methods must be supplemented by a barrier method.
- A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (³ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- Patients who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
- Patients who have received Xofluza for the current influenza infection
- Known contraindication to neuraminidase inhibitors
- Patients weighing < 20 kg
- Patients unable to swallow tablets
- Patients with known severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
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- Patients with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges:
- ALT or AST level > 5 times the upper limit of normal (ULN) or ALT or AST > 3 times the ULN and total bilirubin level > 2 times the ULN
- Pregnant or breastfeeding, or positive pregnancy test in a predose examination, or intending to become pregnant during the study or within 28 days after the last dose of study treatment
- Exposure to an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- Known hypersensitivity to Xofluza (baloxavir marboxil) or the drug product excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Screen and Treat Protocol for Influenza in Socially Vulnerable Communities.
This study seeks to demonstrate that the laboratory can mitigate respiratory virus transmission in underserved populations by using laboratory data to identify communities at risk for increase vial activity (hot spots) and intervening with a test-to-treat model provides increased access to influenza diagnostics and treatment in vulnerable and underserved communities.
Read the detailed description
The investigators have developed an analytic algorithm that uses measures from the CDC COVID-19 Hot Spot Criteria and Brown University School of Public Health to determine COVID-19 and Influenza Hot Spots and Testing Deserts, respectively. The Hot Spot designation was based on the CDC county-specific Hot Spot criteria that has been used to deploy resources for interventions (i.e., laboratory testing, community mitigation, health communications and health care) specific needs for the communities of interest. The CDC hot spot criteria is based on COVID-19 rates at the county level. The adaptations to the criteria allows interventions to focus on a concentrated community and deliver the interventions in places that the community is already engaging, such as community centers, senior centers and parks.
Through collaboration with local community centers, the investigators are able to deploy a mobile testing unit to a community center, park or senior center that is in close proximity to the identified neighborhood for rapid onsite testing for Influenza A\&B and SARS-CoV2 using the cobas Liat system.
New Mexico has adopted "New Mexico Board of Pharmacy Protocol for Pharmacists Prescribing of Dangerous Drugs in Conjunction with Point of Care Testing" (NMBOP POCT Protocol, Appendix 5) that allows pharmacists the prescriptive authority to prescribe Influenza antiviral therapy in conjunction with a positive point of care test (POCT). TriCore employs two (2) on-site clinical pharmacists who will follow all of the pharmacist mandates included in the regulation to prescribe and distribute Xofluza according to the approved protocol in the test-to-treat model presented in this study. The NMBOP PCOT Protocol documents the eligibility and requirements of the certified prescribing pharmacists (pharmacist) following this protocol.
The pharmacist will perform a screening physical assessment, health assessment and medical history for the patient. If the subject meets the inclusion criteria, they will have a point of care test performed. If the subject meets the exclusion criteria, they will be excluded from the study. Testing will be performed using the cobas® SARS-CoV-2 \& Influenza A/B assay on the cobas® Liat® system from a self-collected nasal swab. Subjects who test positive for influenza A or B will be prescribed Xofluza with no additional refills. The pharmacist will follow-up with the patient 24-48 hours following administration for evaluation of signs/symptoms and will refer the patient to their primary care provider, provider, or clinic for recommended laboratory testing and follow-up if appropriate.
All subjects eligible for Xofluza will receive patient education and counseling on drug information, adherence, side effects, and other patient educational materials, as appropriate. All subjects eligible for influenza antiviral therapy, but having contraindications to the therapy, or do not wish to use the therapy will be referred to their primary care provider, provider, or clinic for further evaluation.
Subjects testing positive for SARS-CoV-2 will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. Subjects testing negative for all targets (SARS-CoV-2 and Influenza A\&B) with a high index of suspicion for influenza, will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. All subjects will receive a follow-up call 14-days following the study visit to assess their symptom resolution and the impact of their illness on their well-being
The mobile testing unit will be deployed a minimum of 2 times per week following the determination of the influenza season by the New Mexico Department of Health. The investigators expect to screen 50-100 patients per week for the duration of the influenza season (approximately 12 weeks) for a total of 600-1,2000 patients. With an anticipated 10% positivity rate for influenza, the investigators expect at least 5-10 patients per week to be eligible for treatment for a total of 60-120 subjects eligible over the course of the study. All subjects will be provided a survey to evaluated their ability to access respiratory virus testing and their acceptance of and trust in using a mobile unit for access to treatment and therapeutics. Patients positive for SARS-CoV-2 will be counseled on options for treatment and follow up for COVID-19 infection. All subjects enrolled in the study will receive a follow-up phone call 14-days following the initial screening visit.
- Conditions
- Influenza
- Being tested
- Baloxavir Marboxil
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baloxavir MarboxilDrug
Subjects testing positive for influenza will receive a dose of Baloxavir Marboxil orally, according to the dosing indicated in the package insert.
| Study group | Role | What they receive |
|---|---|---|
| Influenza Positive | Subjects testing positive will receive baloxavir marboxil as a single oral dose as soon as possible and within 48-hours of influenza symptom onset. Dosing will be delivered based on the package insert Receives: Drug: Baloxavir Marboxil | |
| Influenza Negative | Subjects testing negative for influenza will have no drug administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Status
Patients who receive treatment are asked if symptoms are improving or worsening during the treatment follow up call, 14 days after treatment
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start15 Jan 2024
- Primary completion31 May 2024
- Study completion1 Jul 2024
Why it stopped: Limited enrollment opportunities due to low rates of viral infections
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.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tricore, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Crossey, MD, PhD, Principal investigator, Medical Director, Tricore Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207058
- Sponsor's protocol ID
- Tricore
- Status last verified
- May 2025
- First submitted
- 5 Jan 2024
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Screen and Treat Protocol for Influenza in Socially Vulnerable Communities.
- ClinicalTrials.gov ID
- NCT06207058
- Acronym / sponsor ID
- Tricore
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Limited enrollment opportunities due to low rates of viral infections
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tricore, IncUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to demonstrate that the laboratory can mitigate respiratory virus transmission in underserved populations by using laboratory data to identify communities at risk for increase vial activity (hot spots) and intervening with a test-to-treat model provides increased access to influenza diagnostics and treatment in vulnerable and underserved communities.
Detailed description
The investigators have developed an analytic algorithm that uses measures from the CDC COVID-19 Hot Spot Criteria and Brown University School of Public Health to determine COVID-19 and Influenza Hot Spots and Testing Deserts, respectively. The Hot Spot designation was based on the CDC county-specific Hot Spot criteria that has been used to deploy resources for interventions (i.e., laboratory testing, community mitigation, health communications and health care) specific needs for the communities of interest. The CDC hot spot criteria is based on COVID-19 rates at the county level. The adaptations to the criteria allows interventions to focus on a concentrated community and deliver the interventions in places that the community is already engaging, such as community centers, senior centers and parks.
Through collaboration with local community centers, the investigators are able to deploy a mobile testing unit to a community center, park or senior center that is in close proximity to the identified neighborhood for rapid onsite testing for Influenza A\&B and SARS-CoV2 using the cobas Liat system.
New Mexico has adopted "New Mexico Board of Pharmacy Protocol for Pharmacists Prescribing of Dangerous Drugs in Conjunction with Point of Care Testing" (NMBOP POCT Protocol, Appendix 5) that allows pharmacists the prescriptive authority to prescribe Influenza antiviral therapy in conjunction with a positive point of care test (POCT). TriCore employs two (2) on-site clinical pharmacists who will follow all of the pharmacist mandates included in the regulation to prescribe and distribute Xofluza according to the approved protocol in the test-to-treat model presented in this study. The NMBOP PCOT Protocol documents the eligibility and requirements of the certified prescribing pharmacists (pharmacist) following this protocol.
The pharmacist will perform a screening physical assessment, health assessment and medical history for the patient. If the subject meets the inclusion criteria, they will have a point of care test performed. If the subject meets the exclusion criteria, they will be excluded from the study. Testing will be performed using the cobas® SARS-CoV-2 \& Influenza A/B assay on the cobas® Liat® system from a self-collected nasal swab. Subjects who test positive for influenza A or B will be prescribed Xofluza with no additional refills. The pharmacist will follow-up with the patient 24-48 hours following administration for evaluation of signs/symptoms and will refer the patient to their primary care provider, provider, or clinic for recommended laboratory testing and follow-up if appropriate.
All subjects eligible for Xofluza will receive patient education and counseling on drug information, adherence, side effects, and other patient educational materials, as appropriate. All subjects eligible for influenza antiviral therapy, but having contraindications to the therapy, or do not wish to use the therapy will be referred to their primary care provider, provider, or clinic for further evaluation.
Subjects testing positive for SARS-CoV-2 will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. Subjects testing negative for all targets (SARS-CoV-2 and Influenza A\&B) with a high index of suspicion for influenza, will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. All subjects will receive a follow-up call 14-days following the study visit to assess their symptom resolution and the impact of their illness on their well-being
The mobile testing unit will be deployed a minimum of 2 times per week following the determination of the influenza season by the New Mexico Department of Health. The investigators expect to screen 50-100 patients per week for the duration of the influenza season (approximately 12 weeks) for a total of 600-1,2000 patients. With an anticipated 10% positivity rate for influenza, the investigators expect at least 5-10 patients per week to be eligible for treatment for a total of 60-120 subjects eligible over the course of the study. All subjects will be provided a survey to evaluated their ability to access respiratory virus testing and their acceptance of and trust in using a mobile unit for access to treatment and therapeutics. Patients positive for SARS-CoV-2 will be counseled on options for treatment and follow up for COVID-19 infection. All subjects enrolled in the study will receive a follow-up phone call 14-days following the initial screening visit.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Positive | – | Drug: Baloxavir MarboxilSubjects testing positive will receive baloxavir marboxil as a single oral dose as soon as possible and within 48-hours of influenza symptom onset. Dosing will be delivered based on the package insert |
| Influenza Negative | – | –Subjects testing negative for influenza will have no drug administered |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals in respiratory hot spots and socially vulnerable communities identified in the algorithm.
Key inclusion criteria (11 listed)
- Adult patients: Signed informed consent by any patient capable of giving consent, or, where the patient is not capable of giving consent, by his or her legal/authorized representative.
- Adolescent patients not able to legally consent: written informed consent for study participation is obtained from patient's parents or legal guardian, with assent as appropriate by the patient, depending on the patient's level of understanding and capability to provide assent
- Age ³ 5 years at the time of signing the Informed Consent Form/Assent Form
- Ability to comply with the study protocol, in the investigator's judgment.
- Presence of (a) fever (≥38.0 °C per tympanic or rectal thermometer; ≥37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
Key exclusion criteria (12 listed)
- Patients who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
- Patients who have received Xofluza for the current influenza infection
- Known contraindication to neuraminidase inhibitors
- Patients weighing < 20 kg
- Patients unable to swallow tablets
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 |
|---|---|---|
| Baloxavir MarboxilSubjects testing positive for influenza will receive a dose of Baloxavir Marboxil orally, according to the dosing indicated in the package insert. | Drug | Influenza Positive |
Primary outcome
Symptom Status
Time frame: 14 Days
Patients who receive treatment are asked if symptoms are improving or worsening during the treatment follow up call, 14 days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Michael Crossey, MD, PhD principal investigator
Medical Director, Tricore Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Tricore, Inc 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 11 inclusion and 12 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 23 May 2025. 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?
Yes. Results are posted in the registry (first posted 23 May 2025). 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?
Symptom Status (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.