BridgeMD
Early Oseltamivir Carboxylate Low Plasma Concentration in Patients Admitted to Intensive Care for Severe Influenza.
EU CTIS ID: 2024-516058-23-00
What this study is testing
To determine the prognostic impact of early plasma underdosing (measured at 48 hours of treatment) of oseltamivir carboxylate (OC) on early morbidity and mortality in patients hospitalized in the ICU for severe influenza infection.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients over 18 years of age
- 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 scheme, beneficiary or beneficiary entitled (excluding AME)
- Patient or, by default, a trusted support person or, by default, an informed family member who has given written consent or patient who has been included in emergency procedures.
You likely can't join if
- Pregnant or breastfeeding woman
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
- For patients not included in emergency situations: Inability, according to the investigator, to understand or refusal to sign the informed consent to participate in the study (non-French-speaking patient).
- Weight less than 40 kg
- Previous treatment with Zanamivir or other antiviral treatment active against influenza virus for more than 24 hours
- Co-infection with another respiratory virus (including SARS CoV-2)
See the full eligibility criteria
- Patients over 18 years of age
- 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 scheme, beneficiary or beneficiary entitled (excluding AME)
- Patient or, by default, a trusted support person or, by default, an informed family member who has given written consent or patient who has been included in emergency procedures.
- Pregnant or breastfeeding woman
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
- For patients not included in emergency situations: Inability, according to the investigator, to understand or refusal to sign the informed consent to participate in the study (non-French-speaking patient).
- Weight less than 40 kg
- Previous treatment with Zanamivir or other antiviral treatment active against influenza virus for more than 24 hours
- Co-infection with another respiratory virus (including SARS CoV-2)
- Administration of medication via nasogastric tube impossible
- Current participation in a therapeutic interventional trial or be in the exclusion period at the end of a clinical trial (drugs that may interact with paracetamol or oseltamivir)
- Patient benefiting from AME (Aide Médicale d'Etat)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.