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Corticosteroid Therapy for Severe Community-Acquired Pneumonia

Primary Purpose

Community Acquired Pneumonia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
methylprednisolone
Normal saline
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

methylprednisolone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Full Information

First Posted
September 16, 2015
Last Updated
September 16, 2015
Sponsor
Peking Union Medical College Hospital
Collaborators
The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Cangzhou Central Hospital, Cangzhou People's Hospital, Affiliated Hospital of Hebei University, Nantong University, The First Affiliated Hospital of Anhui Medical University, Northern Jiangsu Province People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Taishan Medical University Affiliated Hospital, Tianjin Third Central Hospital, Jinhua Central Hospital, Navy General Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02552342
Brief Title
Corticosteroid Therapy for Severe Community-Acquired Pneumonia
Official Title
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Cangzhou Central Hospital, Cangzhou People's Hospital, Affiliated Hospital of Hebei University, Nantong University, The First Affiliated Hospital of Anhui Medical University, Northern Jiangsu Province People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Taishan Medical University Affiliated Hospital, Tianjin Third Central Hospital, Jinhua Central Hospital, Navy General Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
610 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
methylprednisolone
Arm Type
Active Comparator
Arm Description
This group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
Solu-Medrol
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
sodium chloride
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
30-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun XU, MD
Phone
01069159142
Email
xujunfree@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuezhong Yu, MD
Phone
01069159142
Email
yxzpumch@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuezhong Yu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Xu, MD
Phone
01069159142
Email
xujunfree@126.com
First Name & Middle Initial & Last Name & Degree
Xuezhong Yu, MD
Phone
01069159142
Email
yxzpumch@126.com

12. IPD Sharing Statement

Learn more about this trial

Corticosteroid Therapy for Severe Community-Acquired Pneumonia

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