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Trial record 1 of 1 for:    NCT02489578 | China
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A Retrospective Study on Hospitalized Patients With Community-acquired Pneumonia in China (CAP-China) (RSCAP-China)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489578
Recruitment Status : Unknown
Verified October 2015 by Bin Cao, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : July 3, 2015
Last Update Posted : October 16, 2015
Sponsor:
Collaborators:
Beijing Chao Yang Hospital
Beijing Jishuitan Hospital
Beijing Luhe Hospital
Qingdao Municipal Hospital
Qilu Hospital of Shandong University
Beijing Huimin Hospital
China-Japan Friendship Hospital
Linzi Hospital
Second Hospital of Beijing Armed Police Corps
Kunming Yan'an Hospital
Information provided by (Responsible Party):
Bin Cao, Capital Medical University

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 .

Condition or disease Intervention/treatment
Community Acquired Pneumonia Other: other

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia


Intervention Details:
  • Other: other
    retrospective cohort study


Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Duration of intravenous antimicrobial therapy [ Time Frame: 2 weeks ]
    Time from the first dose of intravenous antibiotics to date of stop of intravenous antibiotics ,participants will be followed for the duration of hospital stay

  2. Hospital length of stay [ Time Frame: 2 weeks ]
    Patients will be asked about hospitalization, date, Patients will be asked about hospitalization, date, participants will be asked about the time of admission and discharge

  3. in-hospital mortality [ Time Frame: 2 weeks ]
    Time from date of admission to date of discharge,participants will be followed for the duration of hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3000 patients with community acquired pneumonia who meet the below inclusion/ exclusion criteria will be recruited in China.
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489578


Contacts
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Contact: Bin Cao, MD 86-010-84206264 caobin_ben@163.com
Contact: LI Gu, MD 86-010-85231514 guli2013227@foxmail.com.cn

Locations
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China
China-Japan Friendship Hospital Recruiting
Beijing, China, 100029
Contact: Bin Cao, MD    86-010-84206264    caobin_ben@163.com   
Contact: Li Gu, MD    86-010-85231514    guli2013227@foxmail.com.cn   
Principal Investigator: Bin cao, MD         
Sponsors and Collaborators
Capital Medical University
Beijing Chao Yang Hospital
Beijing Jishuitan Hospital
Beijing Luhe Hospital
Qingdao Municipal Hospital
Qilu Hospital of Shandong University
Beijing Huimin Hospital
China-Japan Friendship Hospital
Linzi Hospital
Second Hospital of Beijing Armed Police Corps
Kunming Yan'an Hospital
Investigators
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Study Chair: Bin Cao, MD China-Japan Friendship Hospital
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bin Cao, MD, Capital Medical University
ClinicalTrials.gov Identifier: NCT02489578    
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Bin Cao, Capital Medical University:
Community Acquired Pneumonia
health care associated pneumonia
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections