Failure and Cardiovascular Events in Community-acquired Pneumonia

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 pathophysiological approach has been recently developed and used to evaluate clinical failure in CAP patients. Clinical failure has been analyzed as related versus unrelated to CAP, considering the role that the pulmonary infection and the inflammatory response played in the development of this outcome. Cardiac events were identified as triggers of clinical failures in a significant percentage of CAP patients. The development of cardiovascular events have been also identified in CAP patients both on admission to the hospital and during hospitalization. However, data on this topic belong to studies evaluating only selected populations of veteran patients with CAP. Understanding clinical failure, as well as cardiovascular events in hospitalized patients with CAP would be useful in order to prevent complications during the hospitalization, to develop new treatment modalities and, thus, to improve outcomes.

The objectives of this international, multicenter, observational, prospective cohort study will be: 1) To define incidence, timing, etiology and risk factors of clinical failure, related vs. unrelated to CAP, in hospitalized patients with CAP; 2) To define incidence, timing, and risk factors for cardiovascular events either on hospital admission or during hospitalization in hospitalized patients with CAP.Consecutive adult patients hospitalized for CAP in acute care hospitals in Europe and US will be enrolled. Daily clinical evaluations. Demographics, history, clinical, radiological, and antibiotic therapy data will be recorded, as well as serum, urinary and respiratory samples will be collected both on admission and during hospitalization from consenting individuals. Patients will be classified as having a CAP-related versus CAP-unrelated failure, according to a pathophysiological classification. Patients will be also classified as having or not a cardiovascular event either on admission or during hospitalization.The following outcomes will be measured:

1\) Incidence, timing, etiology and risk factors of clinical failure related vs. unrelated to CAP; 2) Incidence, timing and risk factors of cardiovascular events; 3)time to clinical stability, length of hospital stay, mortality at hospital discharge, and mortality at 30 and 180 days.

Conditions

• Community-acquired Pneumonia

Sponsors & Collaborators

• University of Milan

  lead OTHER

Principal Investigators

• Francesco Blasi, M.D., PhD · Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy

• Stefano Aliberti, M.D. · Respiratory Department, AO San Gerardo, University of Milan-Bicocca, Monza, Italy

• Julio Ramirez, M.D. · Division of Infectious Diseases, Department of Medicine, University of Louisville, Louisville, Kentucky, USA

• Roberto Cosentini, M.D. · Emergency Medicine Department, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

• Vincenzo Valenti, M.D. · UO Pneumologia, IRCCS Policlinico San Donato, University of Milan, Milan, Italy

• Antonio Voza, M.D. · UO Medicina d'Urgenza, Istituto Clinico Humanitas; Milan, Italy

• Delfino Legnani, M.D. · UO Pneumologia, Ospedale "Luigi Sacco", University of Milan, Milan, Italy

• Alberto Pesci, M.D. · Clinica Pneumologia, Azienda Ospedaliera S. Gerardo di Monza, University of Milano-Bicocca, Monza, Italy

• Luca Richeldi, M.D. · Department of Respiratory Disease, University of Modena and Reggio Emilia, Modena, Italy

• Daiana Stolz, M.D., MPH · Clinic of Pneumology, University Hospital Basel, Petersgraben 4, CH-4031 Basel, Switzerland

• Paula Peyrani, M.D. · Division of Infectious Diseases, University of Louisville, KY; USA

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2012-10-31

Completion

2012-10-31

Countries

• Italy

Study Locations