NCT06269900招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 46
- 主要终点
- Clinical cure rate at the test-of-cure visit (TOC visit)
研究概览
简要总结
Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two criteria among (body temperature > 38°C, leukocytosis>12000 cells per mL, leucopenia <4000 cells per mL 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. Diagnosis is done at least 48 hours after hospital admission.
- •HAP severity defined as a PaO2/FiO2 ratio < 300 under 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.
排除标准
- •Pregnant women (serum or urine test), breastfeeding women.
- •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, such as for COVID-19 infection requiring supplemental oxygen therapy
- •Severe septic shock (norepinephrine > 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) 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,herpes, zona, varicella) or systemic fungal infection
- •Immunosuppression pre-existing to hospitalisation (severe lymphopenia < 500 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.
- •Participation in another drug clinical trial :
- •testing steroids or anti-graft rejection drug or chemotherapy- radiotherapy for cancer
- •And / Or testing a drug regimen with a known interaction with dexamethasone,
- •And / Or whose implementation would alter the HAP-DEX 6-month follow-up, notably the collection of the primary outcome.
- •Situations that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
研究组 & 干预措施
dexamethasone + standard of care
Experimental
- Dexamethasone 0.2mg.kg-1.day-1 intravenous for a minimal duration of 5 days, and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio < 300).
- Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days.
干预措施: Dexamethasone (Drug)
Placebo + Standard of care
Placebo Comparator
- Placebo 0.2mg.kg-1.day-1 intravenous for 5 days and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio < 300).
- Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical cure rate at the test-of-cure visit (TOC visit)
时间窗: Day 8-10
It's a hierarchic procedure. First, we will test the dexamethasone superiority on the clinical cure rate at the test-of-cure visit realized 8 days (acceptable time frame Day 8-10) after randomization or at the ICU discharge (if it occurs before).
The rate of all-cause mortality on Day 28.
时间窗: Day 28
次要结局
- Rate of pleural empyema at Day 28.(Day 28)
- Rate of microbiological failure(Toc 1 day visit)
- Duration of hospitalization and hospital-free days(Month 6)
- Rates of non-respiratory hospital-acquired infection(Day 28)
- Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event)(day 28)
- Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale(month 3, month 6)
- Changes in subjective well-being with the Satisfaction With Life Scale (SWLS)(month 3, month 6)
- Rate of death(Month 3 , Month 6)
- Rate of pneumonia relapse(day 28)
- Antibiotic-free days at Day 28(Day 28)
- Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days(Month 6)
- Rate of gastric ulcer(day 28)
- Changes in health-related quality of life measured with the Short Form (SF)-36(month 3, month 6)
- the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER)(month 6)
研究者
研究点 (46)
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