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Clinical Trials/NCT02492425
NCT02492425
Unknown
Not Applicable

Evaluating the Adherence to Guidelines' Empirical Antibiotic Recommendations and Outcome of Patients Admitted to a Hospital Ward With a Diagnosis of Community-acquired Pneumonia

Capital Medical University1 site in 1 country3,000 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Community Acquired Pneumonia
Sponsor
Capital Medical University
Enrollment
3000
Locations
1
Primary Endpoint
in-hospital clinical failure rate
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China

Detailed Description

In China, the data about current management of patients hospitalized with community acquired pneumonia (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 healthcare associated pneumonia (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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
May 2018
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Capital Medical University
Responsible Party
Principal Investigator
Principal Investigator

Bin Cao

MD

Capital Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients \> or = 14 years of age
  • Patient meets the criteria of community acquired pneumonia
  • Patient meets the criteria of healthcare-associated pneumonia
  • Informed consent to participate in the study is provided

Exclusion Criteria

  • Patients participating in a clinical trial or other intervention studies
  • 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 (e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia)
  • HIV positive

Outcomes

Primary Outcomes

in-hospital clinical failure rate

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

1)a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement, 2) in-hospital mortality, 3) recurrence, defined as signs or symptoms of infection after completion of therapy requiring re-initiation of antibiotics

30-day post-discharge clinical failure rate

Time Frame: discharge up to 5 weeks

rate of re-hospitalization due to pulmonary infection and death during the follow-up period at 30 days post-discharge from hospital

initial antibiotic treatment failure rate

Time Frame: 72 hours

a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement after first dose use of antibiotics to 72h

Secondary Outcomes

  • Duration of antimicrobial therapy(6 weeks)
  • Days of each antimicrobial therapy(6 weeks)
  • Hospital length of stay(2 weeks)
  • Duration of intravenous antimicrobial therapy(2 weeks)
  • Duration of oral antimicrobial therapy(2 weeks)

Study Sites (1)

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