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Failure and Cardiovascular Events in Community-acquired Pneumonia (FAILCAP)

31 décembre 2013 mis à jour par: Francesco Blasi, University of Milan

Clinical Failure and Cardiovascular Events in Hospitalized Patients With Community-Acquired Pneumonia: The Failcap Study

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Pneumonie communautaire

Type d'étude

Observationnel

Inscription (Réel)

2000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Italie
- - Milan, Italie, 20122
    - Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

All consecutive patients admitted to any of the study centers will be screened for study entry. Patients with a diagnosis of community-acquired pneumonia (including those with health-care associated pneumonia) will be evaluated to define study entry criteria

La description

Inclusion Criteria:

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 Criteria:

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Clinical failure Délai: 30 days	Incidence rates for clinical failure will be standardized and reported. Statistically significant differences between clinical failure related vs. unrelated to CAP will be investigated. Timing of clinical failure rates for those with clinical failure related vs. unrelated to pneumonia will be standardized and reported. Etiology and risk factors of clinical failure will be investigated through linear models, in order to identify associations of factors with the outcome and possible independent groups of factors in the explanation of the outcome.	30 days

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Cardiovascular event Délai: 30 days	Incidence rates for each cardiovascular event will be reported and standardized. Etiology and risk factors of cardiovascular events will be investigated through linear models.	30 days
Time to clinical stability Délai: 7 days	A patient will be considered to reach clinical stability when the following criteria will be met in a single day during hospitalization: 1) improved clinical signs (cough and shortness of breath); 2) patient will be afebrile for at least eight hours; 3) improving leukocytosis (decreased at least 10% from the previous day) or PCR or PCT 4) tolerating oral intake. Criteria for clinical stability will be evaluated daily during the first seven days of hospitalization.	7 days
Length of hospital stay Délai: 30 days	Number of days from the date of admission to the date of discharge.	30 days
In-hospital mortality Délai: 30 days	In-hospital mortality will be considered if death by any cause will occur during hospitalization. Patients will be followed from day of admission to day 30; those who remain hospitalized for more than 30 days will be considered alive.	30 days
Adverse events after hospital discharge Délai: up to 180 days after hospital discharge	Data after hospital discharge will be collected during either a visit at clinics or a phone call performed at 30 and 180 days after the diagnosis of CAP was made. Adverse events will be considered if either death, CAP-related vs. CAP-unrelated, or re-hospitalization, CAP-related vs. CAP-unrelated, will occur within 180 days after hospital discharge. In addition, data regarding visits at general practitioner clinic, antibiotic use, cardiovascular events, discharge setting (nursing home, intermediate care facility, home) will be also collected.	up to 180 days after hospital discharge

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Milan

Les enquêteurs

Directeur d'études: Francesco Blasi, M.D., PhD, Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
Chercheur principal: Stefano Aliberti, M.D., Respiratory Department, AO San Gerardo, University of Milan-Bicocca, Monza, Italy
Directeur d'études: Julio Ramirez, M.D., Division of Infectious Diseases, Department of Medicine, University of Louisville, Louisville, Kentucky, USA
Chercheur principal: Roberto Cosentini, M.D., Emergency Medicine Department, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy
Chercheur principal: Vincenzo Valenti, M.D., UO Pneumologia, IRCCS Policlinico San Donato, University of Milan, Milan, Italy
Chercheur principal: Antonio Voza, M.D., UO Medicina d'Urgenza, Istituto Clinico Humanitas; Milan, Italy
Chercheur principal: Delfino Legnani, M.D., UO Pneumologia, Ospedale "Luigi Sacco", University of Milan, Milan, Italy
Chercheur principal: Alberto Pesci, M.D., Clinica Pneumologia, Azienda Ospedaliera S. Gerardo di Monza, University of Milano-Bicocca, Monza, Italy
Chercheur principal: Luca Richeldi, M.D., Department of Respiratory Disease, University of Modena and Reggio Emilia, Modena, Italy
Chercheur principal: Daiana Stolz, M.D., MPH, Clinic of Pneumology, University Hospital Basel, Petersgraben 4, CH-4031 Basel, Switzerland
Chercheur principal: Paula Peyrani, M.D., Division of Infectious Diseases, University of Louisville, KY; USA

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2009

Achèvement primaire (Réel)

1 octobre 2012

Achèvement de l'étude (Réel)

1 octobre 2012

Dates d'inscription aux études

Première soumission

10 juin 2010

Première soumission répondant aux critères de contrôle qualité

11 juin 2010

Première publication (Estimation)

14 juin 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 janvier 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 décembre 2013

Dernière vérification

1 décembre 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

FAILCAP

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