Failure and Cardiovascular Events in Community-acquired Pneumonia (FAILCAP)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical Failure and Cardiovascular Events in Hospitalized Patients With Community-Acquired Pneumonia: The Failcap Study|
- Clinical failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Cardiovascular event [ Time Frame: 30 days ] [ Designated as safety issue: No ]Incidence rates for each cardiovascular event will be reported and standardized. Etiology and risk factors of cardiovascular events will be investigated through linear models.
- Time to clinical stability [ Time Frame: 7 days ] [ Designated as safety issue: No ]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.
- Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]Number of days from the date of admission to the date of discharge.
- In-hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Adverse events after hospital discharge [ Time Frame: up to 180 days after hospital discharge ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
Urine Sputum Blood Exhaled Breath Condensate Tracheal Aspirate Pleural effusion Bronchoalveolar lavage Nasopharyngeal swabs
|Study Start Date:||October 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143155
|Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Study Director:||Francesco Blasi, M.D., PhD||Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy|
|Principal Investigator:||Stefano Aliberti, M.D.||Respiratory Department, AO San Gerardo, University of Milan-Bicocca, Monza, Italy|
|Study Director:||Julio Ramirez, M.D.||Division of Infectious Diseases, Department of Medicine, University of Louisville, Louisville, Kentucky, USA|
|Principal Investigator:||Roberto Cosentini, M.D.||Emergency Medicine Department, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy|
|Principal Investigator:||Vincenzo Valenti, M.D.||UO Pneumologia, IRCCS Policlinico San Donato, University of Milan, Milan, Italy|
|Principal Investigator:||Antonio Voza, M.D.||UO Medicina d'Urgenza, Istituto Clinico Humanitas; Milan, Italy|
|Principal Investigator:||Delfino Legnani, M.D.||UO Pneumologia, Ospedale "Luigi Sacco", University of Milan, Milan, Italy|
|Principal Investigator:||Alberto Pesci, M.D.||Clinica Pneumologia, Azienda Ospedaliera S. Gerardo di Monza, University of Milano-Bicocca, Monza, Italy|
|Principal Investigator:||Luca Richeldi, M.D.||Department of Respiratory Disease, University of Modena and Reggio Emilia, Modena, Italy|
|Principal Investigator:||Daiana Stolz, M.D., MPH||Clinic of Pneumology, University Hospital Basel, Petersgraben 4, CH-4031 Basel, Switzerland|
|Principal Investigator:||Paula Peyrani, M.D.||Division of Infectious Diseases, University of Louisville, KY; USA|