Trial Outcomes & Findings for Evaluation of a Screen and Treat Protocol for Influenza (NCT NCT06207058)

Results Overview

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

Recruitment status

TERMINATED

Target enrollment

25 participants

Primary outcome timeframe

14 Days

Results posted on

2025-05-23

Participant milestones
Measure	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 Baloxavir Marboxil: Subjects testing positive for influenza will receive a dose of Baloxavir Marboxil orally, according to the dosing indicated in the package insert.	Influenza Negative Subjects testing negative for influenza will have no drug administered
Overall Study STARTED	1	24
Overall Study COMPLETED	1	24
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Influenza Positive n=1 Participants 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 Baloxavir Marboxil: Subjects testing positive for influenza will receive a dose of Baloxavir Marboxil orally, according to the dosing indicated in the package insert.	Influenza Negative n=24 Participants Subjects testing negative for influenza will have no drug administered	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	4 Participants n=24 Participants	4 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants	8 Participants n=24 Participants	8 Participants n=25 Participants
Age, Categorical >=65 years	1 Participants n=1 Participants	12 Participants n=24 Participants	13 Participants n=25 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	11 Participants n=24 Participants	12 Participants n=25 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	13 Participants n=24 Participants	13 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: 14 Days

Population: In the study timeframe, only one patient tested positive for influenza and was able to receive the intervention.

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

Outcome measures
Measure	Influenza Positive n=1 Participants 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 Baloxavir Marboxil: Subjects testing positive for influenza will receive a dose of Baloxavir Marboxil orally, according to the dosing indicated in the package insert.	Influenza Negative n=24 Participants Subjects testing negative for influenza will have no drug administered
Symptom Status Improving	1 Participants	15 Participants
Symptom Status Worsening	0 Participants	0 Participants
Symptom Status Did not respond	0 Participants	9 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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