A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of China

• Conditions: Community Acquired Pneumonia

• Registration Number: NCT02492425
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-07-05
• Study First Posted: 2015-07-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-15
• Study Start: 2016-01
• Primary Completion: 2016-12
• Study Completion: 2018-05

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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
initial antibiotic treatment failure rate	72 hours	a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement after first dose use of antibiotics to 72h
in-hospital clinical failure rate	Time from date of admission to discharge up to 1 week	1)a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement, 2) in-hospital mortality, 3) recurrence, defined as signs or symptoms of infection after completion of therapy requiring re-initiation of antibiotics
30-day post-discharge clinical failure rate	discharge up to 5 weeks	rate of re-hospitalization due to pulmonary infection and death during the follow-up period at 30 days post-discharge from hospital

Secondary Outcome Measures

Name	Time	Method
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
Duration of oral antimicrobial therapy	2 weeks	Time from date of administration of first antibiotic to date of discontinuation of last antibiotic
Duration of antimicrobial therapy	6 weeks	Time from date of administration of first antibiotic to date of discontinuation of last antibiotic (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge from hospital post discharge from hospital
Days of each antimicrobial therapy	6 weeks	Time from date of first administration on admission to hospital to date of discontinuation (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge follow-up for each antibiotic

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China