Trial | NCT02552342  Report issue

Title

Corticosteroid Therapy for Severe Community-Acquired Pneumonia
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    610
The purpose of the present study is to assess the efficacy of methylprednisolone as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).

The hypothesis of the study is that methylprednisolone can decrease the mortality of severe CAP without any significant side effects,with reduction of the time to clinical stability and failure rate of treatment.
Study Started
May 31
2015
Primary Completion
May 31
2017
Anticipated
Study Completion
May 31
2017
Anticipated
Last Update
Sep 17
2015
Estimate

Drug methylprednisolone

  • Other names: Solu-Medrol

Drug Normal saline

  • Other names: sodium chloride

methylprednisolone Active Comparator

This group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days

Placebo Placebo Comparator

This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug

Criteria 

Inclusion Criteria:

community-acquired pneumonia
PSI score：4-5
with at least one of following conditions：①CRP ≥150 mg/L,②oxygen index ≤250 , ③bilateral or multi-lober infiltrates in chest image,④ area of pulmonary infiltrates increase >50% with 48 hous,⑤fever higher than 39℃ exceed 72 hours

Exclusion Criteria:

nosocomial Pneumonia
aspiration pneumonia
acute burn injury
gastrointestinal bleeding within the past three months
uncontrolled diabetes mellitus
pregnant or breast feeding
a condition requiring treatment with greater than 0.5 mg/kg/d of prednison or its equivalent
severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
active tuberculosis
preexisting medical condition with a life expectancy of less than 3 months
No Results Posted