2024-516058-23-00招募中3 期
OPTIFLU. Prognostic Impact of Early Oseltamivir Carboxylate Low Plasma Concentration in Critically Ill Patients With Severe Influenza: a Prospective Cohort Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 16
- 主要终点
- The primary endpoint is the number of days alive without invasive mechanical ventilation at D28.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
The primary endpoint is the number of days alive without invasive mechanical ventilation at D28.
The primary endpoint is the number of days alive without invasive mechanical ventilation at D28.
次要结局
- Diagnostic performance of the paracetamol absorption test (sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios) performed at H48 for the diagnosis of plasma oseltamivir underdosing.
- Prevalence of patients with low plasma OC concentration
- Plasma OC underdosage at H48 (dependent variable); the independent variables are the clinical and biological data present on admission, which will be studied as prognostic factors for OC underdosage using univariate and multivariate logistic regression models.
- Viral clearance, calculated from nasopharyngeal viral load measurements taken on D1 (initial influenza diagnostic test) and D5. The association between viral clearance and plasma OC concentration at H48 will be assessed.
- Prevalence of acquisition of the H275Y oseltamivir resistance mutation (investigated by PCR and high-throughput sequencing).
- Measurements of Cmax and Residual OC and oseltamivir phosphate (OP, inactive prodrug) at D2, D3 and D5
- Mortality at D28 and D90 in patients under-dosed in OC at 48h of treatment initiation and in patients not under-dosed
研究者
Coordinating investigator - Dr Anne-Fleur Haudebourg
Scientific
Assistance Publique Hopitaux De Paris
研究点 (16)
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