Corticosteroid Therapy for Severe Community-Acquired Pneumonia
NCT ID: NCT02552342
Last Updated: 2015-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
610 participants
INTERVENTIONAL
2015-05-31
2017-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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methylprednisolone
This group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days
methylprednisolone
Placebo
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug
Normal saline
Interventions
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methylprednisolone
Normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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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 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
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Xuezhong Yu, MD
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JS-836
Identifier Type: -
Identifier Source: org_study_id
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