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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MxA group | Experimental | Perform MxA test; MxA results reported to attending clinicians; Provide MxA-based guidelines on antiviral treatment to attending clinicians; Telephone Visit at Day 30 |
|
| Control group | Active Comparator | Telephone Visit at Day 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MxA tests | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Cao | China-Japan Friendship Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship hospital | Beijing | Beijing Municipality | 100029 | China |
IPD used in the results publication will be shared.
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| MxA feedback | Other | MxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines. |
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| Follow-up at Day 30 | Other | 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. |
|
Defined as the total number of hospital days by Day 30.
| 30 days |
| 30-day mortality | Defined as the proportion of patients who died by Day 30. | 30 days |
| Incidence of mechanical ventilation | Defined as the proportion of patients receiving mechanical ventilation by day 30. | 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. | 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. | 30 days |
| Readmission rate | Defined as the incidence of readmission or additional medical visits within 30 days of enrollment for patients who have been discharged. | 30 days |
| 30-day adverse outcomes | Defined as the incidence of recurrence, death, mechanical ventilation, complications, ICU admission, or readmission or additional medical visits within 30 days of enrollment. | 30 days |
| Total antiviral-days by day 30 | Defined as the total number of days of antiviral treatment from admission to the discontinuation of antiviral therapy by Day 30. | 30 days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |