REMAP-CAP Influenza Antiviral Domain

JRCT ID: jRCTs051240171

Registered date:29/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Influenza infection of severe state
• Date of first enrollment: 29/10/2024
• Target sample size: 5
• Countries of recruitment: Australia,Japan,New Zealand,Japan,Europe,Japan,Canada,Japan,Saudi Arabia,Japan
• Study type: Interventional

Intervention(s)

1. No antiviral agent (no placebo)(Not implemented in Japan due to japanese medical habit)
2. Oseltamivir twice daily for five days
3. Oseltamivir twice daily for ten days
4. Baloxavir on days 1 and 4 after reveal of randomized treatment assignment
5. Oseltamivir twice daily for 5 days + baloxavir on days 1 and 4 after reveal of randomized treatment assignment
6. Oseltamivir twice daily for 10 days + baloxavir on days 1 and 4 after reveal of randomized treatment assignment

Outcome(s)

• Primary Outcome: All-cause mortality at 90 days

Secondary Outcome

1. ICU mortality censored at 90 days
2. ICU LOS censored at 90 days
3. hospital LOS censored at 90 days
4. ventilator free days (VFDs) censored at 28 days
5. organ failure free days (OFFDs) censored at 28 days
6. Proportion of intubated participants who receive a tracheostomy censored at 28 days
7. survival at 6 months
8. Destination at time of hospital discharge (characterized as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital)
9. Readmission to the index ICU during the index hospitalization in the 90 days following enrollment
10. health related quality of life (HRQoL) assessed after 6 months using the EQ5D
11. disability assessed after 6 months using the World Health Organization Disability Assessment Schedule (WHODAS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with
a. symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND
b. Radiological evidence of new onset infiltrate of infective origin (in patients with pre-existing radiological changes, evidence of new infiltrate)
2. Up to 48 hours after ICU admission, receiving organ support with one or more of
a. Non-invasive or invasive ventilatory support
b. Receiving infusion of vasopressor or inotropes or both
3. Influenza infection has been confirmed by microbiological testing

Exclude criteria

1. More than 48 hours has elapsed since ICU admission
2. Healthcare-associated pneumonia
a. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
b. Resident of a nursing home or long-term care facility.
3. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.
4. Previous participation in this REMAP within the last 90 days
5. Patient has already received two or more doses of oseltamivir or other neuraminidase inhibitors
6. Patient has already received one or more doses of baloxavir
7. Patient is already receiving, or a clinical decision has been made to commence, an antiviral active against influenza other than oseltamivir or baloxavir, or both
8. The treating clinician believes that participation in the domain would not be in the best interests of the patient
9. Known hypersensitivity to an agent specified as an intervention in this domain will exclude a patient from receiving that agent
10. Known or suspected pregnancy will result in exclusion from interventions that include baloxavir
11. Severe renal impairment (eGFR<=10mL/min/1.73m2) or receiving renal replacement therapy

Related Information

• Primary Sponsor: Fujitani Shigeki
• Source(s) of Monetary Support: Shionogi &amp; Co., Ltd.,Japan Science and Technology Agency