Informations générales (source: ClinicalTrials.gov)
Prognostic Impact of Early Oseltamivir Carboxylate Low Plasma Concentration in Critically Ill Patients With Severe Influenza: a Prospective Cohort Study
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2022
mars 2025
18 septembre 2025
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.
Etablissements
Critères
Tous
Inclusion Criteria:
- Adult patients
- Confirmed severe influenza infection requiring intensive care with tracheal
intubation for invasive mechanical ventilation (influenza ARDS with or without
bacterial co-infection, cardiorespiratory decompensation of influenza origin,
influenza myocarditis)
- Oseltamivir treatment administered through a gastric tube initiated since less than
24 hours (i.e. maximum two doses administered)
- Affiliation to a social security system or beneficiary (excluding AME)
- Written consent obtained (or under emergency procedures)
- Adult patients
- Confirmed severe influenza infection requiring intensive care with tracheal
intubation for invasive mechanical ventilation (influenza ARDS with or without
bacterial co-infection, cardiorespiratory decompensation of influenza origin,
influenza myocarditis)
- Oseltamivir treatment administered through a gastric tube initiated since less than
24 hours (i.e. maximum two doses administered)
- Affiliation to a social security system or beneficiary (excluding AME)
- Written consent obtained (or under emergency procedures)
- Pregnancy or breastfeeding women
- Weight less than 40 kg
- Zanamivir or other antiviral effective treatment received for more than 24 hours
- Other respiratory virus infection (including SARS-CoV-2)
- Contra-indication to esophageal tube insertion or use
- Child-Pugh C cirrhosis or severe liver insufficiency
- Paracetamol allergy
- Ongoing participation in an interventional therapeutic trial (medicine that may
interact with paracetamol or oseltamivir)
- Patient benefiting from AME (State Medical Aid)
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
- For patients not included in an emergency situation: Inability, according to the
investigator, to understand or refusal to sign the informed consent to participate
in the study (non-French-speaking patient).