Corticosteroid Therapy for Severe Community-Acquired Pneumonia

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02552342

Enrollment

610

Registered

2015-09-17

Start date

2015-05-31

Completion date

2017-05-31

Last updated

2015-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Pneumonia

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.

Interventions

DRUGmethylprednisolone

DRUGNormal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
All cause mortality	30-days

Countries

China

Contacts

Primary ContactJun XU, MD

xujunfree@126.com01069159142

Backup ContactXuezhong Yu, MD

yxzpumch@126.com01069159142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026