Community-acquired PneumoniaFAILCAPNCT01143155
Failure and Cardiovascular Events in Community-acquired Pneumonia
An observational study of Community-acquired Pneumonia, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2009to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: 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:
- 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
- Keywords
- Pneumonia, Community-acquired pneumonia, Healthcare-associated pneumonia, Failure, Cardiovascular events, Outcome
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Healthcare-Associated Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical failure
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.
Measured: 30 days
Secondary outcomes (5)
Cardiovascular event
Incidence rates for each cardiovascular event will be reported and standardized. Etiology and risk factors of cardiovascular events will be investigated through linear models.
Measured: 30 days
Time to clinical stability
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.
Measured: 7 days
Length of hospital stay
Number of days from the date of admission to the date of discharge.
Measured: 30 days
In-hospital mortality
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.
Measured: 30 days
Adverse events 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.
Measured: up to 180 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Blasi, University of Milan
- Investigators
- Francesco Blasi, M.D., PhD, Study director, Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, ItalyStefano Aliberti, M.D., Principal investigator, Respiratory Department, AO San Gerardo, University of Milan-Bicocca, Monza, ItalyJulio Ramirez, M.D., Study director, Division of Infectious Diseases, Department of Medicine, University of Louisville, Louisville, Kentucky, USARoberto Cosentini, M.D., Principal investigator, Emergency Medicine Department, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, ItalyVincenzo Valenti, M.D., Principal investigator, UO Pneumologia, IRCCS Policlinico San Donato, University of Milan, Milan, ItalyAntonio Voza, M.D., Principal investigator, UO Medicina d'Urgenza, Istituto Clinico Humanitas; Milan, ItalyDelfino Legnani, M.D., Principal investigator, UO Pneumologia, Ospedale "Luigi Sacco", University of Milan, Milan, ItalyAlberto Pesci, M.D., Principal investigator, Clinica Pneumologia, Azienda Ospedaliera S. Gerardo di Monza, University of Milano-Bicocca, Monza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143155
- Sponsor's protocol ID
- FAILCAP
- Acronym
- FAILCAP
- Status last verified
- Dec 2013
- First submitted
- 10 Jun 2010
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Niederman MS, Mandell LA, Anzueto A, Bass JB, Broughton WA, Campbell GD, Dean N, File T, Fine MJ, Gross PA, Martinez F, Marrie TJ, Plouffe JF, Ramirez J, Sarosi GA, Torres A, Wilson R, Yu VL; American Thoracic Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001 Jun;163(7):1730-54. doi: 10.1164/ajrccm.163.7.at1010. No abstract available.
PubMed 11401897Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.
PubMed 17278083Aliberti S, Amir A, Peyrani P, Mirsaeidi M, Allen M, Moffett BK, Myers J, Shaib F, Cirino M, Bordon J, Blasi F, Ramirez JA. Incidence, etiology, timing, and risk factors for clinical failure in hospitalized patients with community-acquired pneumonia. Chest. 2008 Nov;134(5):955-962. doi: 10.1378/chest.08-0334. Epub 2008 Jun 26.
PubMed 18583514Ramirez J, Aliberti S, Mirsaeidi M, Peyrani P, Filardo G, Amir A, Moffett B, Gordon J, Blasi F, Bordon J. Acute myocardial infarction in hospitalized patients with community-acquired pneumonia. Clin Infect Dis. 2008 Jul 15;47(2):182-7. doi: 10.1086/589246.
PubMed 18533841Musher DM, Rueda AM, Kaka AS, Mapara SM. The association between pneumococcal pneumonia and acute cardiac events. Clin Infect Dis. 2007 Jul 15;45(2):158-65. doi: 10.1086/518849. Epub 2007 Jun 6.
PubMed 17578773Jasti H, Mortensen EM, Obrosky DS, Kapoor WN, Fine MJ. Causes and risk factors for rehospitalization of patients hospitalized with community-acquired pneumonia. Clin Infect Dis. 2008 Feb 15;46(4):550-6. doi: 10.1086/526526.
PubMed 18194099Mortensen EM, Coley CM, Singer DE, Marrie TJ, Obrosky DS, Kapoor WN, Fine MJ. Causes of death for patients with community-acquired pneumonia: results from the Pneumonia Patient Outcomes Research Team cohort study. Arch Intern Med. 2002 May 13;162(9):1059-64. doi: 10.1001/archinte.162.9.1059.
PubMed 11996618
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Failure and Cardiovascular Events in Hospitalized Patients With Community-Acquired Pneumonia: The Failcap Study
- ClinicalTrials.gov ID
- NCT01143155
- Acronym / sponsor ID
- FAILCAP / FAILCAP
- Conditions
- Community-acquired Pneumonia
- Keywords
- Pneumonia, Community-acquired pneumonia, Healthcare-associated pneumonia, Failure, Cardiovascular events, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 1) Signed inform consent to participate in the study
- New pulmonary infiltrate seen on chest radiograph or CT Scan of the chest within 48 hours after hospitalization.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical failure
Time frame: 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.
5 secondary outcomes
Cardiovascular event
Time frame: 30 days
Time to clinical stability
Time frame: 7 days
Length of hospital stay
Time frame: 30 days
In-hospital mortality
Time frame: 30 days
Adverse events after hospital discharge
Time frame: up to 180 days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
- Background: PubMed 11401897Niederman MS, Mandell LA, Anzueto A, Bass JB, Broughton WA, Campbell GD, Dean N, File T, Fine MJ, Gross PA, Martinez F, Marrie TJ, Plouffe JF, Ramirez J, Sarosi GA, Torres A, Wilson R, Yu VL; American Thoracic Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001 Jun;163(7):1730-54. doi: 10.1164/ajrccm.163.7.at1010. No abstract available.
- Background: PubMed 17278083Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.
- Background: PubMed 18583514Aliberti S, Amir A, Peyrani P, Mirsaeidi M, Allen M, Moffett BK, Myers J, Shaib F, Cirino M, Bordon J, Blasi F, Ramirez JA. Incidence, etiology, timing, and risk factors for clinical failure in hospitalized patients with community-acquired pneumonia. Chest. 2008 Nov;134(5):955-962. doi: 10.1378/chest.08-0334. Epub 2008 Jun 26.
- Background: PubMed 18533841Ramirez J, Aliberti S, Mirsaeidi M, Peyrani P, Filardo G, Amir A, Moffett B, Gordon J, Blasi F, Bordon J. Acute myocardial infarction in hospitalized patients with community-acquired pneumonia. Clin Infect Dis. 2008 Jul 15;47(2):182-7. doi: 10.1086/589246.
- Background: PubMed 17578773Musher DM, Rueda AM, Kaka AS, Mapara SM. The association between pneumococcal pneumonia and acute cardiac events. Clin Infect Dis. 2007 Jul 15;45(2):158-65. doi: 10.1086/518849. Epub 2007 Jun 6.
- Background: PubMed 18194099Jasti H, Mortensen EM, Obrosky DS, Kapoor WN, Fine MJ. Causes and risk factors for rehospitalization of patients hospitalized with community-acquired pneumonia. Clin Infect Dis. 2008 Feb 15;46(4):550-6. doi: 10.1086/526526.
- Background: PubMed 11996618Mortensen EM, Coley CM, Singer DE, Marrie TJ, Obrosky DS, Kapoor WN, Fine MJ. Causes of death for patients with community-acquired pneumonia: results from the Pneumonia Patient Outcomes Research Team cohort study. Arch Intern Med. 2002 May 13;162(9):1059-64. doi: 10.1001/archinte.162.9.1059.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Blasi, M.D., PhD study director
Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
Stefano Aliberti, M.D. principal investigator
Respiratory Department, AO San Gerardo, University of Milan-Bicocca, Monza, Italy
Julio Ramirez, M.D. study director
Division of Infectious Diseases, Department of Medicine, University of Louisville, Louisville, Kentucky, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical failure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143155, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.