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Clinical Trials/NCT02489578
NCT02489578UnknownNot Applicable

Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China

Capital Medical University1 site in 1 country3,000 target enrollmentStarted: July 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
3,000
Locations
1
Primary Endpoint
treatment failure at 72h after initiation of antibiotics

Study Overview

Brief Summary

The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China .

Detailed Description

In China, the data about current management of patients hospitalized with CAP in the real-life setting is not available,type of pneumonia, selection of initial antibiotic, time to clinical stability, antibiotic choice anf modification,clinical outcomes and costs remain unclear.

In this study, we will collect comprehensive information on CAP and HCAP management patterns to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China .to analyze microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of patients with CAP (> and = 65 years, different comorbidities ,risk factors) ,to investigate microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of disease severity with CAP ,to provide the difference on microbiological characteristics,clinical manifestations,antibiotic regimens ,and outcome between patients with CAP and HCAP ,to understand the current situation of antibiotic regimen ,to evaluate influence of different antibiotic regimens on prognosis.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
14 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients > or = 14 years of age
  • Patient meets the criteria of community acquired pneumonia
  • Patient meets the criteria of healthcare-associated pneumonia

Exclusion Criteria

  • Patients <14 years of age
  • Patient meets the criteria of hospital acquired pneumonia
  • Known active tuberculosis or current treatment for tuberculosis
  • Non-infectious pulmonary diseases
  • HIV positive

Outcomes

Primary Outcomes

treatment failure at 72h after initiation of antibiotics

Time Frame: Time from the first dose use of antibiotics to 72 hours

treatment failure was defined as a change of antibiotics due to worsening signs or symptoms associated with pneumonia

in-hospital treatment failure due to multiple causes

Time Frame: Time from date of admission to discharge up to 1 week

1)death in hospital;2)change of antibiotics due to worsening signs or symptoms of infection, 3) recurrence, defined as signs or symptoms of infection after completion of therapy requiring re-initiation of antibiotics

Secondary Outcomes

  • in-hospital mortality(2 weeks)
  • Duration of intravenous antimicrobial therapy(2 weeks)
  • Hospital length of stay(2 weeks)

Investigators

Sponsor
Capital Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bin Cao

MD

Capital Medical University

Study Sites (1)

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