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

Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China

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 .

Study Overview

• Status: Unknown
• Conditions: Community Acquired Pneumonia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: LI Gu, MD; Phone Number: 86-010-85231514; Email: guli2013227@foxmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
in-hospital mortality	Time from date of admission to date of discharge,participants will be followed for the duration of hospital stay	2 weeks

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Qilu Hospital of Shandong University; Beijing Chao Yang Hospital; Qingdao Municipal Hospital; China-Japan Friendship Hospital; Beijing Jishuitan Hospital; Beijing Luhe Hospital; Beijing Huimin Hospital; Linzi Hospital; Second Hospital of Beijing Armed Police Corps; Kunming Yan'an Hospital
• Investigators: Study Chair: Bin Cao, MD, China-Japan Friendship Hospital

Publications and helpful links

General Publications

• 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. Epub 2013 Nov 26.
• 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/chest.13-1186.
• 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 pneumoniae in adults and adolescents with community-acquired pneumonia. BMC Infect Dis. 2013 Apr 11;13:172. doi: 10.1186/1471-2334-13-172.
• Han X, Liu X, Chen L, Wang Y, Li H, Zhou F, Xing X, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Cao B; CAP-China network. Disease burden and prognostic factors for clinical failure in elderly community acquired pneumonia patients. BMC Infect Dis. 2020 Sep 12;20(1):668. doi: 10.1186/s12879-020-05362-3.
• Han X, Zhou F, Li H, Xing X, Chen L, Wang Y, Zhang C, Liu X, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Purdy JE, Cao B; CAP-China network. Effects of age, comorbidity and adherence to current antimicrobial guidelines on mortality in hospitalized elderly patients with community-acquired pneumonia. BMC Infect Dis. 2018 Apr 24;18(1):192. doi: 10.1186/s12879-018-3098-5.
• Chen L, Zhou F, Li H, Xing X, Han X, Wang Y, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Uyeki TM, Wang C, Cao B; CAP-China network. Disease characteristics and management of hospitalised adolescents and adults with community-acquired pneumonia in China: a retrospective multicentre survey. BMJ Open. 2018 Feb 15;8(2):e018709. doi: 10.1136/bmjopen-2017-018709.

Helpful Links

• Related Info
• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Community Acquired Pneumonia; health care associated pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: NCT20150101