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

• Conditions: Community Acquired Pneumonia

• Registration Number: NCT02489578
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study First Submitted: 2015-03-16
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
in-hospital mortality	2 weeks	Time from date of admission to date of discharge,participants will be followed for the duration of hospital stay
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
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

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China