This pilot randomized controlled trial (RCT) will investigate the clinical impact of Myxovirus Resistance Protein A (MxA)-guided antiviral treatment versus standard treatment in patients with respiratory viral infections.
Effective antiviral treatment would shorten the time to symptom resolution, accelerate the cessation of viral shedding, and improve the prognosis of respiratory viral infections. However, the optimal timing for antiviral treatment remains undetermined, and the current lack of objective biomarkers for respiratory viral infections often leads to either prolonged or insufficient antiviral treatment. Thus, there is a need for strategies that incorporate novel diagnostics to guide antiviral treatment and provide more individualized therapy. Myxovirus resistance protein A (MxA), a novel marker of viral infection, may hold potential in guiding antiviral therapy. In this pilot randomized controlled clinical study, we aim to evaluate whether MxA-guided antiviral treatment, as compared to standard care, can reduce the recurrence rate of respiratory viral infections and improve clinical outcomes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
Whole blood samples will be collected on Days 1, 4, 7, and 10 for MxA testing. MxA measurements on Days 4, 7, and 10 will be performed only for patients still hospitalized on antiviral thearpy or at the attending physician's discretion.
MxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines.
A telephone visit will be conducted on or around Day 30 for study participants who are discharged, to collect information on antiviral usage, recurrence infection, readmissions, and additional medical visits.
China-Japan Friendship hospital
Beijing, Beijing Municipality, China
RECRUITING30-Day recurrence rate
Recurrence is defined as the worsening of symptoms and a positive viral PCR test from respiratory samples in patients who discontinued antiviral treatment within 30 days of enrollment.
Time frame: 30 days
Antiviral-days by day 30
Defined as the total number of days of antiviral treatment from randomization to the discontinuation of antiviral therapy by Day 30.
Time frame: 30 days
Length of hospital stay
Defined as the total number of hospital days by Day 30.
Time frame: 30 days
30-day mortality
Defined as the proportion of patients who died by Day 30.
Time frame: 30 days
Incidence of mechanical ventilation
Defined as the proportion of patients receiving mechanical ventilation by day 30.
Time frame: 30 days
Incidence of complications
Defined as the incidence of complications such as bronchitis and viral pneumonia occurring within 30 days of enrollment in patients with an initial diagnosis of upper respiratory viral infection.
Time frame: 30 days
ICU admission rate
Defined as the incidence of transfer to the ICU within 30 days of enrollment for patients initially admitted to a general ward.
Time frame: 30 days
Readmission rate
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Defined as the incidence of readmission or additional medical visits within 30 days of enrollment for patients who have been discharged.
Time frame: 30 days