Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02489578 | China
Previous Study | Return to List | Next Study

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

Tracking Information
First Submitted Date March 16, 2015
First Posted Date July 3, 2015
Last Update Posted Date October 16, 2015
Study Start Date July 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2015)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2015)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study on Hospitalized Patients With Community-acquired Pneumonia in China (CAP-China)
Official Title Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Community Acquired Pneumonia
Intervention Other: other
retrospective cohort study
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 1, 2015)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
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

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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02489578
Other Study ID Numbers Not Provided
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bin Cao, Capital Medical University
Study Sponsor Capital Medical University
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
Investigators
Study Chair: Bin Cao, MD China-Japan Friendship Hospital
PRS Account Capital Medical University
Verification Date October 2015