2024-511896-13-00招募中4 期
Use of MULTIplex PCR, procalcitonin and the appearance of sputum to reduce the duration of antibiotic therapy during severe COPD EXAcerbation: a trial controlled, randomized, open, in parallel groups, multicenter (MULTI-EXA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 13
- 主要终点
- Number of days alive without antibiotics on D28.
研究概览
简要总结
Evaluate the effectiveness in terms of antibiotic sparing of a personalized diagnostic and therapeutic strategy, compared to a usual strategy, during EA-COPD in the ICU/Rea.
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
- 否
入选标准
- •Age ≥ 18 years old
- •Post-smoking COPD confirmed according to GOLD 2020, whatever the stage (I-IV)
- •Acute exacerbation (defined by the appearance or increase of one or more of the usual signs/symptoms of COPD) with acute respiratory failure requiring admission to the ICU/Resuscitation and mechanical ventilation (invasive or non-invasive or nasal oxygen therapy high flow rate with FiO2 ≥ 50%)
- •Consent (patient, relative or inclusion in emergency situation)
- •Affiliation to a social security scheme.
排除标准
- •Delay between admission to hospital and admission to ICU/ICU greater than 3 days
- •Current pregnancy.
- •Antibiotic therapy formally indicated for a suspected or documented extra-respiratory infection
- •Congenital or acquired immunosuppression (congenital immune deficiency, progressive high-grade hematological malignancy, immunosuppressive drugs in the last 30 days including cytotoxic anti-cancer chemotherapy and anti-rejection drugs, corticosteroid therapy ≥ 20 mg/d of prednisone equivalent for at least 14 days, neutropenia, HIV with unknown or known CD4<200/µL in the last 6 months)
- •Tracheotomy
- •Bronchial dilatation/cystic fibrosis
- •Moribund patient (imminent death)
- •Patient deprived of liberty and/or protected by law
- •Patient already included in MULTI-EXA
- •Patient already included in a type 1 interventional clinical study (RIPH1) relating to antibiotics
结局指标
主要结局
Number of days alive without antibiotics on D28.
Number of days alive without antibiotics on D28.
次要结局
- Incidence rate of nosocomial pneumonia on day 28;
- Number of days with antibiotics in patients alive on D28
- Number of days with broad-spectrum antibiotics in patients alive on D28
- Incidence rate of colonization/infection with multi-resistant bacteria on day 28;
- Duration of stay in ICU/ICU at D28,
- Length of hospital stay on D28;
- Number of days alive without mechanical ventilation on D28
- - Incidence rate of hospital-acquired pneumonia (including ventilator-acquired pneumonia) on day 28;
- Mortality in ICU/ICU and in hospital (on day 28 and day 90);
- - Number of additional EA-COPD(s) (requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) after the index EA-COPD (at D90);
- Time between the index EA-COPD and the next EA-COPD (EA-COPD requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) (at D90);
- CAT questionnaire (COPD Assessment Test) (at D90).
研究者
Stanislas Quenard
Scientific
Assistance Publique Hopitaux De Paris
研究点 (13)
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