Evaluation of a Screen and Treat Protocol for Influenza

NCT06207058 | Terminated Results FDA Drug

• 1 other identifier: Tricore
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 treatment in vulnerable and underserved communities.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Symptom Status

  Patients who receive treatment are asked if symptoms are improving or worsening during the treatment follow up call, 14 days after treatment

  14 Days

Study Arms (2)

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

Drug: Baloxavir Marboxil

Influenza Negative

Subjects testing negative for influenza will have no drug administered

Interventions

Baloxavir Marboxil DRUG

Subjects testing positive for influenza will receive a dose of Baloxavir Marboxil orally, according to the dosing indicated in the package insert.

Influenza Positive

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals in respiratory hot spots and socially vulnerable communities identified in the algorithm.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tricore, Inc: lead

Study Sites (1)

TriCore Mobile Unit

Albuquerque, New Mexico, 87120, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

baloxavir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Tricore

michael.crossey@tricore.org

505-938-8461

Study Officials

• Michael Crossey, MD, PhD

  Medical Director, Tricore Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: January 15, 2024
• Primary Completion: May 31, 2024
• Study Completion: July 1, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Locations

US (1)