SYFfc2435f7cb4043aca2d786662dfb46f4Registry ID: 2024-513209-30-00|RecruitingPhase 3
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interventional
N/A
1 country
11
To compare the percentage of patients hospitalized with influenza according to treatment arm (oseltamivir-dexamethasone vs oseltamivir-placebo) with status 3 or higher according to the Hospital Recovery Scale (status 3: hospitalization with supplemental oxygen, or 4: ICU admission without invasive mechanical ventilation, or 5: with invasive mechanical ventilation, or 6: death) on day 7 after the start of treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 18, 2024
Actual (reported)Percentage of patients in status greater than or equal to 3 (3,4,5 or 6) according to the Hospital Recovery Scale (HRS) on day 7 after the start of treatment.
Time elapsed in days between the start of treatment and clinical stability, defined by NEWS-2<2 scale for >24 hours or hospital discharge (first event).
Hospital stay: expressed in days, taken from the discharge date and date of admission.
Admission to the ICU: from any cause, and related or not to influenza (or its secondary complications) in the opinion of the researcher. Discharge date and date of admission.
Need or not for non-invasive mechanical ventilation (NIMV), with the start/end date.
Need or not for invasive mechanical ventilation (IMV) with the admission/discharge date.
Hospital Universitario Virgen De La Macarena
Sevilla, 41009, Spain
Hospital Universitario 12 De Octubre
Madrid, 28041, Spain
Hospital General Universitario De Valencia
Valencia, 46014, Spain
Javier Mateo
First Submitted
July 18, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Hospital Vega Baja De Orihuela
Orihuela, 03325, Spain
Hospital General Universitario Santa Lucia
Cartagena, 30202, Spain
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
Murcia, 30120, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
University Clinical Hospital Virgen De La Arrixaca
Murcia, 30120, Spain
Hospital Universitario Virgen De Valme
Sevilla, 41014, Spain
Hospital Clinico Universitario De Valencia
Valencia, 46010, Spain
Hospital General Universitario De Elche
Elche, 03203, Spain