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

2013年12月31日 更新者：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.

調査の概要

状態

完了

条件

研究の種類

観察的

入学 (実際)

2000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イタリア
      • Milan、イタリア、20122
        • Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Clinical failure
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Cardiovascular event
時間枠：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
時間枠：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
時間枠：30 days
Number of days from the date of admission to the date of discharge.
30 days
In-hospital mortality
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Milan

捜査官

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年10月1日

一次修了 (実際)

2012年10月1日

研究の完了 (実際)

2012年10月1日

試験登録日

最初に提出

2010年6月10日

QC基準を満たした最初の提出物

2010年6月11日

最初の投稿 (見積もり)

2010年6月14日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年1月3日

QC基準を満たした最後の更新が送信されました

2013年12月31日

最終確認日

2013年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FAILCAP

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