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临床试验/NCT00908713
NCT00908713已完成4 期

Corticoids in Severe Community-acquired Pneumonia

Hospital Clinic of Barcelona3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
3
主要终点
Rate of non-response to empiric antimicrobial treatment

研究概览

简要总结

The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.

详细描述

Community acquired pneumonia (CAP) is associated with a local and systemic inflammatory response conducted by different pro and counter inflammatory cytokines. The evolution of the infection is mainly dependent on the intensity of the inflammatory response. The AIM of the project is to determine the clinical usefulness of methylprednisolone treatment (0,5 mg/ Kg weight every 12h for 5 days in patients with severe CAP and an excessive inflammatory response( patients identified based on a cut-off point of the reactive C protein (RCP) of 15 mg/dl). A randomized double blind placebo controlled study with two arms will be performed: The study group (patients with excessive inflammatory response) will receive methylprednisolone + antibiotics. Control group will receive placebo + antibiotics. Patients older than 18 years with Fine V pneumonia will be recruited. Clinical data and prognostic factors (APACHE II and, SOFA scores, etiology, mortality at ICU and at 28 days) will be collected.

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

入选标准

  • Severe community-acquired pneumonia Fine V
  • CRP >=15 mg/100 mL

排除标准

  • Major contraindications for corticosteroids, such as uncontrolled diabetes, immunosuppression
  • Previous glucocorticoid treatment during the previous month
  • Documented extrapulmonary infection
  • Previous hospitalization in the previous month

研究组 & 干预措施

methylprednisolone

Experimental

methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days

干预措施: methylprednisolone (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Rate of non-response to empiric antimicrobial treatment

时间窗: 5 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Agusti

Consultor Senior

Hospital Clinic of Barcelona

研究点 (3)

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