Corticosteroid Therapy for Severe Community-Acquired Pneumonia

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Community Acquired Pneumonia

Treatments: Drug: methylprednisolone; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02552342

JS-836

Details and patient eligibility

About

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.

Enrollment: 610 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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610 participants in 2 patient groups, including a placebo group

methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: methylprednisolone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline