NCT02552342

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
610

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

September 16, 2015

Last Update Submit

September 16, 2015

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    30-days

Study Arms (2)

methylprednisolone

ACTIVE COMPARATOR

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

Drug: methylprednisolone

Placebo

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

methylprednisoloneDRUG
Also known as: Solu-Medrol
methylprednisolone
Normal salineDRUG
Also known as: sodium chloride
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

MethylprednisoloneMethylprednisolone HemisuccinateSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Xuezhong Yu, MD

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Jun XU, MD

CONTACT

01069159142xujunfree@126.com

Xuezhong Yu, MD

CONTACT

01069159142yxzpumch@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 17, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

CN(1)