Clinical trial NCT02492425: A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of China
Official title: Evaluating the Adherence to Guidelines' Empirical Antibiotic Recommendations and Outcome of Patients Admitted to a Hospital Ward With a Diagnosis of Community-acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Community Acquired Pneumonia
Keywords: Community Acquired Pneumonia
Healthcare Associated Pneumonia
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 HCAP in real life of China

Detailed description: In China, the data about current management of patients hospitalized with community acquired pneumonia (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 healthcare associated pneumonia (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
* Informed consent to participate in the study is provided

Exclusion Criteria:

* Patients participating in a clinical trial or other intervention studies
* 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 （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia）
* HIV positive

Primary outcomes:
measure: initial antibiotic treatment failure rate
timeFrame: 72 hours
measure: in-hospital clinical failure rate
timeFrame: Time from date of admission to discharge up to 1 week
measure: 30-day post-discharge clinical failure rate
timeFrame: discharge up to 5 weeks
Secondary outcomes:
measure: Duration of intravenous antimicrobial therapy
timeFrame: 2 weeks
measure: Duration of oral antimicrobial therapy
timeFrame: 2 weeks
measure: Duration of antimicrobial therapy
timeFrame: 6 weeks
measure: Days of each antimicrobial therapy
timeFrame: 6 weeks
measure: Hospital length of stay
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.