Dexamethasone for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype, an international phase III, double-blind, placebo-controlled, randomized trial - the HAP-DEX study - RC23_0358

Centre Hospitalier Universitaire De Nantes0 个研究点目标入组 450 人开始时间: 2023年10月6日最近更新: 2024年7月22日

适应症

试验速览

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•Adult patients (18yr to 85yr), Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two clinical criteria (body temperature > 38°C and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (Sputum, AET, BAL, mini–BAL or blind BAL) collected for bacteriological diagnosis (results can be pending at inclusion). The diagnosis of HAP can have been made outside of ICU but at least 48 hours after hospital admission., Severity defined as a PaO2/FiO2 ratio < 200 under invasive mechanical ventilation., Biological systemic inflammatory response defined as CPR> 150 mg/L (15 mg/dL), Receiving curative antimicrobial therapy for the current episode of HAP pneumonia for less than 48 hours., Informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). If it is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible., Person insured under a health insurance scheme., Female of childbearing age who agree and who are able to comply with effective contraception for the 28 first days of the study: sexual abstinence, use of a condom with spermicide, contraceptive sponge, uterine diaphragm, hormonal contraception, or intrauterine contraceptive device

•Pregnant women (serum or urine test), breastfeeding women., Participation in another drug clinical trial, Patient under legal protection (incl. under guardianship or trusteeship)., Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients, Ongoing administration of glucocorticoid at the time of randomisation., Prolonged use of corticosteroids at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for >3 weeks in the past 60 days, Uncontrolled viral (hepatitis, zona, varicella) or systemic fungal infection, Immunosuppression (severe lymphopenia < 750 lymphocytes/mm3, hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug)., Uncontrolled psychotic disorder (acute or chronical), Patients not expected to survive for more than 48 hours

发起方

Centre Hospitalier Universitaire De Nantes