NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051240171

Registered date:29/10/2024

REMAP-CAP Influenza Antiviral Domain

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedInfluenza infection of severe state
Date of first enrollment10/12/2024
Target sample size5
Countries of recruitmentAustralia,Japan,New Zealand,Japan,Europe,Japan,Canada,Japan,Saudi Arabia,Japan
Study typeInterventional
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 OutcomeAll-cause mortality at 90 days
Secondary Outcome1. 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 maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Naho Shimodaira
Address Dainikyubiru 4F, Bakurocho 1-6-8, Nihonbashi, chuo-ku, Tokyo, Japan Tokyo Japan 103-0002
Telephone +81-3-6667-0250
E-mail shimodaira@deelites.jp
Affiliation Dee Lites Co.,Ltd
Scientific contact
Name Shigeki Fujitani
Address 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511,Japan Kanagawa Japan 216-8511
Telephone +81-44-977-8111
E-mail shigekifujitani@marianna-u.ac.jp
Affiliation St. Marianna University Hospital