Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting (NCT06762587) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting
China372 participantsStarted 2025-01-05
Plain-language summary
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.
Who can participate
Age range2 Years
SexALL
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Inclusion Criteria:
* Index patient:
* 1\. Patients or accompanying caregivers hospitalized at participating medical institutions.
* 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and completion of all study procedures and assessments.
* 3.Age ≥ 2 years.
* 4.Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
* Close contact:
* 1.Patients or accompanying caregivers hospitalized at participating medical institutions.
* 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and complete all study procedures and assessments
* 3.Age ≥ 12 years.
* 4.Expected to remain hospitalized for ≥ 72 hours.
* 5.The room must contain at least one hospitalized index patient diagnosed with influenza virus within the past 72 hours, and the contact is expected to stay with the hospitalized index patient in the ward for more than 24 hours.
* 6.Throat swab on the first day tested negative for influenza virus by PCR.
Exclusion Criteria:
* Close contacts
* 1.With known allergies to the active ingredients or excipients of the investigational drug.
* 2.Close contacts diagnosed with or having experienced an influenza virus infection within the…
What they're measuring
1
Incidence of Clinical Influenza within a 5-day period