Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC
试验速览
- 阶段
- 3 期
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients. Mortality remains high for those patients with comorbidities (50% for patients with the most severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with PcP has been associated with decreased mortality but in non-HIV patients, adjunctive steroids remains controversy. Some retrospective studies in that field did not find any beneficial effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the studies were retrospective, non randomised studies including various underlying disease and severity of PcP was variable. Moreover, dosage and delay of steroids were variable leading difficult to interpret all the results.
The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV immunocompromised patients with a double blinded randomised clinical trials comparing adjunctive steroids to placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Severe PcP : 1 / interstitial acute pneumonia with possible or typical criteria for PcP and positive specimen for Pneumocystis jirovecii (excluding PCR) ; or interstitial acute pneumonia with typical criteria for PcP and positive PCR in respiratory specimen. 2/ Arterial pression of Oxygen (PaO2) < 60 mmHg on room air need of 3 L/min oxygen for saturation >92% or tachypnea>30min need of mechanical ventilation for acute respiratory failure.
- •Treatment for PcP started for less than 7 days.
- •Non-HIV immunosuppression : malignant hematological disease, solid tumor cured for less than 5 years, allogenic stem cell transplant, Steroids (>0.3mg/kg equivalent prednisone for more than 3 weeks or > 20mg/days for more than one months) or other immunosuppressive treatment for more than one months or solid organ transplantation.
- •Signed inform consent by patient or relatives
- •Health insurance
排除标准
- •HIV Serology HIV 1 or 2 positive
- •Need of steroid ≥1mg/kg/j equivalent prednisone for another pathology (acute Graft versus Host disease (GVH= for example)
- •Contra-indication for steroids
- •Pregnancy of breath-feeding
- •Denied to participate
- •No health insurance
研究组 & 干预措施
Placebo
Saline serum, same volume as in the Experimental arm.
干预措施: Placebo (Drug)
Steroids
Methylprednisolone intra veinous
- Day 1 to 5 : 30mg twice per day
- Day 6 to 10 : 30mg per day
- Day 11 to 21 : 20mg per day
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Mortality
时间窗: Day 28
28 days mortality after the randomisation
次要结局
- Occurrence of septic shock(Day 28)
- ICU length of stay(Day 90)
- Hospital mortality(Day 120)
- Hospital length of stay(Day 120)
- ICU mortality(Day 90)
- acute kidney injury(Day 28)
- Hospital acquired infectious disease(Day 28)
- Mortality(Day 90)
- Acute respiratory failure(Day 28)
- Duration of mechanical ventilation(Day 28)
- Duration of Insulin treatment(Day 28)