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Administrative data

NCT number NCT02489578
Other study ID # NCT20150101
Secondary ID
Status Unknown status
Phase N/A
First received March 16, 2015
Last updated October 14, 2015
Start date July 2015
Est. completion date December 2016

Study information

Verified date October 2015
Source Capital Medical University
Contact Bin Cao, MD
Phone 86-010-84206264
Email caobin_ben@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 3000
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
other
retrospective cohort study

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing

Sponsors (11)

Lead Sponsor Collaborator
Capital Medical University Beijing Chao Yang Hospital, Beijing Huimin Hospital, Beijing Jishuitan Hospital, Beijing Luhe Hospital, China-Japan Friendship Hospital, Kunming Yan'an Hospital, Linzi Hospital, Qilu Hospital of Shandong University, Qingdao Municipal Hospital, Second Hospital of Beijing Armed Police Corps

Country where clinical trial is conducted

China, 

References & Publications (3)

Cao B, Huang GH, Pu ZH, Qu JX, Yu XM, Zhu Z, Dong JP, Gao Y, Zhang YX, Li XH, Liu JH, Wang H, Xu Q, Li H, Xu W, Wang C. Emergence of community-acquired adenovirus type 55 as a cause of community-onset pneumonia. Chest. 2014 Jan;145(1):79-86. doi: 10.1378/ — View Citation

Qu J, Gu L, Wu J, Dong J, Pu Z, Gao Y, Hu M, Zhang Y, Gao F, Cao B, Wang C; Beijing Network for Adult Community-Acquired Pneumonia (BNACAP). Accuracy of IgM antibody testing, FQ-PCR and culture in laboratory diagnosis of acute infection by Mycoplasma pneu — View Citation

Yang SQ, Qu JX, Wang C, Yu XM, Liu YM, Cao B. Influenza pneumonia among adolescents and adults: a concurrent comparison between influenza A (H1N1) pdm09 and A (H3N2) in the post-pandemic period. Clin Respir J. 2014 Apr;8(2):185-91. doi: 10.1111/crj.12056. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary treatment failure at 72h after initiation of antibiotics treatment failure was defined as a change of antibiotics due to worsening signs or symptoms associated with pneumonia Time from the first dose use of antibiotics to 72 hours
Primary in-hospital treatment failure due to multiple causes 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 Time from date of admission to discharge up to 1 week
Secondary Duration of intravenous antimicrobial therapy 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 weeks
Secondary Hospital length of stay 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 2 weeks
Secondary in-hospital mortality Time from date of admission to date of discharge,participants will be followed for the duration of hospital stay 2 weeks
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