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Corticosteroid Therapy for Severe Community-Acquired Pneumonia

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02552342
Collaborator
The Second Hospital of Hebei Medical University (Other), Tianjin Medical University General Hospital (Other), Cangzhou Central Hospital (Other), Cangzhou People's Hospital (Other), Affiliated Hospital of Hebei University (Other), Nantong University (Other), The First Affiliated Hospital of Anhui Medical University (Other), Northern Jiangsu Province People's Hospital (Other), First Affiliated Hospital of Wenzhou Medical University (Other), Zhejiang University (Other), Taishan Medical University Affiliated Hospital (Other), Tianjin Third Central Hospital (Other), Jinhua Central Hospital (Other), Navy General Hospital, Beijing (Other)
610
Enrollment
1
Location
2
Arms
24
Duration (Months)
25.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
610 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial
Study Start Date :
May 1, 2015
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality [30-days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital
    • 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

    Investigators

    • Study Director: Xuezhong Yu, MD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT02552342
    Other Study ID Numbers:
    • JS-836
    First Posted:
    Sep 17, 2015
    Last Update Posted:
    Sep 17, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Pneumonia
    Methylprednisolone
    Methylprednisolone Acetate
    Methylprednisolone Hemisuccinate
    Prednisolone
    Prednisolone acetate
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Sep 17, 2015