Status:
UNKNOWN
Early Oseltamivir Carboxylate Low Plasma Concentration in Patients Admitted to Intensive Care for Severe Influenza
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Severe Influenza
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 r...
Detailed Description
Methods Prospective cohort study conducted in 22 French intensive care units. Adult patients admitted to the ICU for severe influenza requiring invasive mechanical ventilation and treated with oselta...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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).
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT05375864
Start Date
December 1 2022
End Date
March 1 2025
Last Update
December 9 2022
Active Locations (1)
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1
Anne-Fleur Haudebourg
Créteil, France, 94010