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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
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This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.
This study will enroll hospitalized patients diagnosed with influenza virus infection (index patients) and their roommates who are not infected with the influenza virus (close contacts). The close contacts will be randomly assigned in a 1:1:1 ratio to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis. The incidence of clinical influenza (confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) testing, along with fever and one respiratory symptom) will be monitored to evaluate the efficiency of antiviral prophylaxis in a hospital setting. The index patients will receive standard treatment for influenza infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baloxavir Marboxil | Experimental | Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg. |
|
| Oseltamivir Arm | Experimental | Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day |
|
| Control Arm | No Intervention | No antivirals will be administered to the contacts. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baloxavir Marboxil | Drug | Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Clinical Influenza within a 5-day period | Incidence of Clinical Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom. | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of influenza within a 5-day period | Incidence of Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT). | up to 5 days |
| Incidence of Clinical Influenza within a 10-day period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeming Wang, Ph.D. | Contact | +86 84206264 | wwyymm_love@163.com | |
| Ziyi Chu | Contact | +86 18168859689 | ziyichu123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Cao, Ph.D | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000628402 | baloxavir |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Oseltamivir | Drug | Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day. |
|
Incidence of Clinical Influenza within a 10-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom. |
| up to 10 days |
| Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation | Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation is defined as the percentage of contacts infected with resistance-associated treatment-emergent influenza variants. | up to 10 days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |