Corticosteroid Therapy for Severe Community-Acquired Pneumonia

September 16, 2015 updated by: Peking Union Medical College Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

610

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: methylprednisolone
This group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days
Drug: methylprednisolone
Other Names:
  • Solu-Medrol
PLACEBO_COMPARATOR: Placebo
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug
Drug: Normal saline
Other Names:
  • sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 30-days
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

The First Affiliated Hospital of Anhui Medical University
The Second Hospital of Hebei Medical University
Affiliated Hospital of Hebei University
Tianjin Medical University General Hospital
Zhejiang University
Northern Jiangsu Province People's Hospital
Nantong University
Tianjin Third Central Hospital
First Affiliated Hospital of Wenzhou Medical University
Cangzhou Central Hospital
Jinhua Central Hospital
Navy General Hospital, Beijing
Cangzhou People's Hospital
Taishan Medical University Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (ESTIMATE)

September 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-836

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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