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Prognostic Impact of Early Oseltamivir Carboxylate Low Plasma Concentration in Critically Ill Patients With Severe Influenza: a Prospective Cohort Study
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
155
1 country
1
Study Start
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Introduction Pandemic and seasonal influenza epidemics can be associated with a high degree of morbidity and mortality, especially in patients developing severe influenza pneumonitis with the acute respiratory distress syndrome (ARDS) or the less frequent fulminant myocarditis. Early administration (i.e. in the first 48 hours) of the neuraminidase inhibitor oseltamivir is associated with reduced mortality in patients hospitalized for severe influenza. Early oseltamivir administration, which can only be given orally (or through a nasogastric tube), is thus recommended by the World Health Organization in patients hospitalized for severe influenza, including those requiring intensive care (ICU) admission. However, enteric absorption may be compromised in critically ill patients due to impaired gut function. Hypothesis/Objective The hypothese is that, in patients admitted for severe influenza, early (i.e., measured at the 48th hour of treatment initiation) oseltamivir carboxylate (OC) low plasma concentration would be: 1) associated with a poor prognosis; and 2) detectable by carrying out a paracetamol absorption test (PAT). The main objective of the study is to determine the prognostic impact of early OC low plasma concentration in patients admitted to the intensive care unit (ICU) for severe influenza. Primary outcome measure: Number of live ventilator-free days at 28-day in patients with versus without OC low plasma concentration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2022
Actual (reported)May 17, 2022
Actual (reported)December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Live ventilator-free days (VFDs)
VFDs = 0 if subject dies within 28 days of mechanical ventilation. VFDs = 28 - x if successfully liberated from ventilation x days after initiation. VFDs = 0 if the subject is mechanically ventilated for \> 28 days.
Day 28
Diagnostic performance of the paracetamol absorption test (PAT)
48 hours
Prevalence of patients with low plasma OC concentration
48 hours
Paracetamol's administration (1 gram) - 48 hours after oseltamivir administration.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Tamiflu 75 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
DOLIPRANE 1000 mg, poudre pour solution buvable en sachet-dose
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Tamiflu 75 mg hard capsules
Named ingredient: Oseltamivir
View registry recordDOLIPRANE 1000 mg, poudre pour solution buvable en sachet-dose
Named ingredient: Paracetamol
View registry recordAnne-Fleur Haudebourg
Créteil, 94010, France
Anne-Fleur Haudebourg, M.D
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
First Submitted
May 9, 2022
First Posted
May 17, 2022
Study Start
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Independent variables present on admission associated with low plasma OC concentration
48 hours
Prevalence of acquisition early OC concentration and viral clearance
48 hours
Prevalence of acquisition of the oseltamivir resistance mutation (H275Y) in patients with versus without low plasma OC concentration.
48 hours and day 5
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December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 9, 2022
Record last verified: 2022-11
DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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