Clinical trial NCT02489578: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Community Acquired Pneumonia
Keywords: Community Acquired Pneumonia
health care associated pneumonia
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Beijing Jishuitan Hospital
name: Beijing Luhe Hospital
name: Qingdao Municipal Hospital
name: Qilu Hospital of Shandong University
name: Beijing Huimin Hospital
name: China-Japan Friendship Hospital
name: Linzi Hospital
name: Second Hospital of Beijing Armed Police Corps
name: Kunming Yan'an Hospital
First posted: 2015-07-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: treatment failure at 72h after initiation of antibiotics
timeFrame: Time from the first dose use of antibiotics to 72 hours
measure: in-hospital treatment failure due to multiple causes
timeFrame: Time from date of admission to discharge up to 1 week
Secondary outcomes:
measure: Duration of intravenous antimicrobial therapy
timeFrame: 2 weeks
measure: Hospital length of stay
timeFrame: 2 weeks
measure: in-hospital mortality
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bin Cao, MD
role: STUDY_CHAIR
References:
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. Epub 2013 Nov 26.
citation: 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.
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 pneumoniae in adults and adolescents with community-acquired pneumonia. BMC Infect Dis. 2013 Apr 11;13:172. doi: 10.1186/1471-2334-13-172.
citation: 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.
citation: 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.
citation: 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.