Corticosteroid Therapy for Severe Community-Acquired Pneumonia

Community Acquired Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02552342
• Other study ID #: JS-836
• Status: Recruiting
• Phase: Phase 4
• First received: September 16, 2015
• Last updated: September 16, 2015
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: September 2015
• Source: Peking Union Medical College Hospital
• Contact: Jun XU, MD
• Phone: 01069159142
• Email: xujunfree[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 610
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• community-acquired pneumonia

• PSI score:4-5

• with at least one of following conditions:?CRP =150 mg/L,?oxygen index =250 , ?bilateral or multi-lober infiltrates in chest image,? area of pulmonary infiltrates increase >50% with 48 hous,?fever 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• methylprednisolone

• Normal saline

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (15)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Affiliated Hospital of Hebei University, Affiliated hospital of Taishan medical university, Cangzhou Central Hospital, Cangzhou People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Jinhua Central Hospital, Nantong University, Navy general hospital PLA China, People's hospital of northern Jiangsu province, The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Tianjin Third Central Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		30-days	No