Status:
COMPLETED
Failure and Cardiovascular Events in Community-acquired Pneumonia
Lead Sponsor:
University of Milan
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
18+ years
Brief Summary
Although failure and mortality are the most relevant outcomes in patients with Community-acquired Pneumonia (CAP), there is little discussion in the literature on their incidence and etiology. A patho...
Eligibility Criteria
Inclusion
- 1\) Signed inform consent to participate in the study
- 2\) Criteria for community-acquired pneumonia:
- New pulmonary infiltrate seen on chest radiograph or CT Scan of the chest within 48 hours after hospitalization.
- plus at least one of the following:
- New or increased cough with/without sputum production
- Fever (documented temperature -rectal or oral- \> 38.3 or hypothermia (documented temperature -rectal or oral- \< 36 C)
- Evidence of systemic inflammation (such as abnormal white blood cell count -either leukocytosis (\> 10,000/cm3) or leukopenia (\< 4,000/cm3) - or C-reactive protein (CRP) or procalcitonin (PCT) values above the local upper limit.
- 3\) Patients with a diagnosis of healthcare-associated pneumonia (HCAP) will be included in the study and a secondary analysis will performed on this subgroup of patients.
Exclusion
- Patients who meet at least one of the following definitions will be excluded from the analysis:
- Patient has hospital-acquired pneumonia, defined as pneumonia that develops after 48 hours of the current hospitalization, or pneumonia that develops in a patient who had been discharged from the hospital within the prior 14 days of the current hospitalization.
- Patient is re-admitted with a new episode of pneumonia during the 14-day follow up period from the previous hospitalization.
- Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.
- Subject history that in the investigator's opinion would preclude subject compliance with the protocol.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT01143155
Start Date
October 1 2009
End Date
October 1 2012
Last Update
January 3 2014
Active Locations (1)
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1
Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy, 20122