CAP-China: A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of China
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients > or = 14 years of age
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Patient meets the criteria of community acquired pneumonia
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Patient meets the criteria of healthcare-associated pneumonia
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Informed consent to participate in the study is provided
Exclusion Criteria:
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Patients participating in a clinical trial or other intervention studies
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Patients <14 years of age
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Patient meets the criteria of hospital acquired pneumonia
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Known active tuberculosis or current treatment for tuberculosis
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Non-infectious pulmonary diseases （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia）
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HIV positive
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | Beijing | China | 100029 |
Sponsors and Collaborators
- Capital Medical University
Investigators
- Study Chair: Bin Cao, MD, China-Japan Friendship Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- NCT20150401