Corticosteroid Therapy for Severe Community-Acquired Pneumonia

Phase 4

• Conditions: Community Acquired Pneumonia
• Interventions: Drug: Normal saline; Drug: methylprednisolone

• Registration Number: NCT02552342
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-16
• Last Update Submitted: 2015-09-16
• Study First Posted: 2015-09-17
• Last Update Posted: 2015-09-17
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 610

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal saline	This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug
methylprednisolone	methylprednisolone	This group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days

Primary Outcome Measures

Name	Time	Method
All cause mortality	30-days

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China