RSCAP-China: A Retrospective Study on Hospitalized Patients With Community-acquired Pneumonia in China (CAP-China)

Sponsor
Capital Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02489578
Collaborator
Beijing Chao Yang Hospital (Other), Beijing Jishuitan Hospital (Other), Beijing Luhe Hospital (Other), Qingdao Municipal Hospital (Other), Qilu Hospital of Shandong University (Other), Beijing Huimin Hospital (Other), China-Japan Friendship Hospital (Other), Linzi Hospital (Other), Second Hospital of Beijing Armed Police Corps (Other), Kunming Yan'an Hospital (Other)
3,000
1
17.1
175.9

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jul 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Outcome Measures

Primary Outcome Measures

  1. treatment failure at 72h after initiation of antibiotics [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 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 [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 [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 [2 weeks]

    Time from date of admission to date of discharge,participants will be followed for the duration of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China-Japan Friendship Hospital Beijing China 100029

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

  • Study Chair: Bin Cao, MD, China-Japan Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bin Cao, MD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT02489578
Other Study ID Numbers:
  • NCT20150101
First Posted:
Jul 3, 2015
Last Update Posted:
Oct 16, 2015
Last Verified:
Oct 1, 2015
Keywords provided by Bin Cao, MD, Capital Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2015