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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Blasi, University of Milan
ClinicalTrials.gov Identifier:
NCT01143155
First received: June 10, 2010
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition
Community-acquired Pneumonia

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 2000
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

1) Signed inform consent to participate in the study

2) Criteria for community-acquired pneumonia:

  1. 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:

  2. New or increased cough with/without sputum production
  3. Fever (documented temperature -rectal or oral- > 38.3 or hypothermia (documented temperature -rectal or oral- < 36 C)
  4. 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:

  1. 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.
  2. Patient is re-admitted with a new episode of pneumonia during the 14-day follow up period from the previous hospitalization.
  3. Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.
  4. Subject history that in the investigator's opinion would preclude subject compliance with the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143155

Locations
Italy
Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy, 20122
Sponsors and Collaborators
University of Milan
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Francesco Blasi, Professor, University of Milan
ClinicalTrials.gov Identifier: NCT01143155     History of Changes
Other Study ID Numbers: FAILCAP
Study First Received: June 10, 2010
Last Updated: December 31, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
Pneumonia
Community-acquired pneumonia
Healthcare-associated pneumonia
Failure
Cardiovascular events
Outcome

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 28, 2014