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Clinical trialNCT01143155CompletedObservational

Failure and Cardiovascular Events in Community-acquired Pneumonia

SponsorUniversity of MilanEnrollment2,000Community-acquired Pneumonia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Alberto Pesci, M.D.

    Clinica Pneumologia, Azienda Ospedaliera S. Gerardo di Monza, University of Milano-Bicocca, Monza, Italy

    Principal Investigator
  • Antonio Voza, M.D.

    UO Medicina d'Urgenza, Istituto Clinico Humanitas; Milan, Italy

    Principal Investigator
  • Daiana Stolz, M.D., MPH

    Clinic of Pneumology, University Hospital Basel, Petersgraben 4, CH-4031 Basel, Switzerland

    Principal Investigator
  • Delfino Legnani, M.D.

    UO Pneumologia, Ospedale "Luigi Sacco", University of Milan, Milan, Italy

    Principal Investigator
  • Francesco Blasi, M.D., PhD

    Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy

    Study Director
  • Julio Ramirez, M.D.

    Division of Infectious Diseases, Department of Medicine, University of Louisville, Louisville, Kentucky, USA

    Study Director
  • Luca Richeldi, M.D.

    Department of Respiratory Disease, University of Modena and Reggio Emilia, Modena, Italy

    Principal Investigator
  • Paula Peyrani, M.D.

    Division of Infectious Diseases, University of Louisville, KY; USA

    Principal Investigator
  • Roberto Cosentini, M.D.

    Emergency Medicine Department, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

    Principal Investigator
  • Stefano Aliberti, M.D.

    Respiratory Department, AO San Gerardo, University of Milan-Bicocca, Monza, Italy

    Principal Investigator
  • Vincenzo Valenti, M.D.

    UO Pneumologia, IRCCS Policlinico San Donato, University of Milan, Milan, Italy

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Italy
  • Dipartimento Toraco-Polmonare E Cardio-Circolatorio, University of Milan, Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico

    Milan, Italy

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2009
Primary completion
31 Oct 2012
Completion
31 Oct 2012
Last update posted
3 Jan 2014
Registered enrollment
2,000
Registry id
NCT01143155

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.