<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02224716</url>
  </required_header>
  <id_info>
    <org_study_id>FIS-ANT-2014-01</org_study_id>
    <nct_id>NCT02224716</nct_id>
  </id_info>
  <brief_title>Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals</brief_title>
  <official_title>Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza Progreso y Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Andalusian Network for Design and Translation of Advanced Therapies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of a structured package (bundle) in&#xD;
      reducing the use of antimicrobials and hospital stay of patients with community-acquired&#xD;
      pneumonia (CAP), and no increase in mortality of these patients in different hospitals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Antimicrobial use in patients hospitalized for CAP.</measure>
    <time_frame>twelve months</time_frame>
    <description>It is measured in defined daily doses (DDD) per 100 hospital stay of patients hospitalized with CAP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality rate to 30 days</measure>
    <time_frame>twelve months</time_frame>
    <description>Number of death of patients hospitalized with CAP, stratified by CURB-65 score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CAP severity CURB-65 or PSI registered.</measure>
    <time_frame>twelve months</time_frame>
    <description>Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):&#xD;
Numbers of doctors who register on the clinical history the evaluation of CAP severity by CURB-65 or PSI at hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological samples at admission.</measure>
    <time_frame>twelve months</time_frame>
    <description>Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):&#xD;
Numbers of doctors who taking all microbiological samples recommended in the guideline in the first 6 hours of patient admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appropriate supportive treatment</measure>
    <time_frame>Twelve months</time_frame>
    <description>Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):&#xD;
Number of doctors who take supportive treatment according to guideline during the hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empirical treatment</measure>
    <time_frame>Twelve months</time_frame>
    <description>Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):&#xD;
Number of doctors who prescribed empirical treatment according to the guideline at admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appropriate sequential therapy.</measure>
    <time_frame>Twelve months</time_frame>
    <description>Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):&#xD;
Number of doctors who switch to oral therapy according to guideline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific antimicrobial treatment</measure>
    <time_frame>Twelve months</time_frame>
    <description>Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):&#xD;
Number of doctors who prescribed the specific antimicrobial treatment defined in the guideline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total duration of antibiotic therapy.</measure>
    <time_frame>Twelve months</time_frame>
    <description>Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):&#xD;
Number of doctors who prescribe an antimicrobial treatment during 7 days or less, or 5 days or less after clinical improvement.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">968</enrollment>
  <condition>Community Acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>Pre-intervention All patients admitted with a diagnosis of CAP</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Post intervention All patient admitted with a diagnosis of CAP</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pre-intervention period&#xD;
&#xD;
        All patients admitted with a diagnosis of CAP will be included in the participating centers&#xD;
        during the 12 months prior to the intervention. Case detection is done through the&#xD;
        electronic record of the basic minimum data set (MDS) (2, 36). Diagnosed patients will be&#xD;
        selected at discharge: &quot;simple acute bronchitis and pneumonia excluding asthma major&#xD;
        criteria&quot; (by diagnosis related group, DRG 541) and &quot;simple and pleuritis in over 17&#xD;
        Pneumonia&quot; (DRG 089).&#xD;
&#xD;
        Post-intervention period&#xD;
&#xD;
        All patients admitted with a diagnosis of CAP in the participating centers, which measures&#xD;
        the bundle will apply prospectively included. Case detection was performed by daily review&#xD;
        of patients admitted to target units and will be coordinated by the IP address of each&#xD;
        center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of CAP at hospital admission .&#xD;
&#xD;
          -  Age: 18 years or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with nosocomial pneumonia or criteria related to health care.&#xD;
&#xD;
          -  Patients with severe immunosuppression (HIV infection with &lt;200 CD4+ lymphocytes /&#xD;
             mm3), neutropenia (&lt;500 neutrophils / mm3).&#xD;
&#xD;
          -  Patient treated with immunosuppressive drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pilar Retamar Gentil</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario Virgen Macarena</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Enrique Corzo Delgado</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Virgen de Valme</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cristina Roca Oporto</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospitales Universitarios Virgen del Rocío</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Montserrat Pérez Pérez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de la Línea de la Concepción</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salvador López Cardenas</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Jerez de la Frontera</affiliation>
  </overall_official>
  <overall_official>
    <last_name>María del Carmen Almodóvar Pulido</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Antequera</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernando Nebrera Navarro</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Formentera</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosario Javier Martínez</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Virgen de las Nieves</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisca Guerrero Sánchez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Puerta del Mar</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pilar Retamar Gentil</last_name>
    <phone>0034 955 04 04 50</phone>
    <email>gestionensayosclinicos.fps@juntadeandalucia.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fundación Pública Progreso y Salud</name>
      <address>
        <city>Sevilla</city>
        <zip>41092</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María del Mar Benjumea Vargas</last_name>
      <phone>0034955040450</phone>
      <email>gestionensayosclinicos.fps@juntadeandalucia.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>June 11, 2015</last_update_submitted>
  <last_update_submitted_qc>June 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224716
org study id: FIS-ANT-2014-01
nct id: NCT02224716
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the impact of a structured package (bundle) in
      reducing the use of antimicrobials and hospital stay of patients with community-acquired
      pneumonia (CAP), and no increase in mortality of these patients in different hospitals.
observational model: Cohort
measure: Antimicrobial use in patients hospitalized for CAP.
time frame: twelve months
description: It is measured in defined daily doses (DDD) per 100 hospital stay of patients hospitalized with CAP.
measure: Mortality rate to 30 days
time frame: twelve months
description: Number of death of patients hospitalized with CAP, stratified by CURB-65 score.
measure: CAP severity CURB-65 or PSI registered.
time frame: twelve months
description: Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):
Numbers of doctors who register on the clinical history the evaluation of CAP severity by CURB-65 or PSI at hospitalization.
measure: Microbiological samples at admission.
time frame: twelve months
description: Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):
Numbers of doctors who taking all microbiological samples recommended in the guideline in the first 6 hours of patient admission.
measure: Appropriate supportive treatment
time frame: Twelve months
description: Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):
Number of doctors who take supportive treatment according to guideline during the hospitalization.
measure: Empirical treatment
time frame: Twelve months
description: Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):
Number of doctors who prescribed empirical treatment according to the guideline at admission.
measure: Appropriate sequential therapy.
time frame: Twelve months
description: Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):
Number of doctors who switch to oral therapy according to guideline.
measure: Specific antimicrobial treatment
time frame: Twelve months
description: Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):
Number of doctors who prescribed the specific antimicrobial treatment defined in the guideline
measure: Total duration of antibiotic therapy.
time frame: Twelve months
description: Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no):
Number of doctors who prescribe an antimicrobial treatment during 7 days or less, or 5 days or less after clinical improvement.
arm group label: Pre-intervention All patients admitted with a diagnosis of CAP
arm group label: Post intervention All patient admitted with a diagnosis of CAP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pilar Retamar Gentil
role: Study Director
affiliation: Hospital Universitario Virgen Macarena
last name: Juan Enrique Corzo Delgado
role: Principal Investigator
affiliation: Hospital Universitario Virgen de Valme
last name: Cristina Roca Oporto
role: Principal Investigator
affiliation: Hospitales Universitarios Virgen del Rocío
last name: Montserrat Pérez Pérez
role: Principal Investigator
affiliation: Hospital de la Línea de la Concepción
last name: Salvador López Cardenas
role: Principal Investigator
affiliation: Hospital de Jerez de la Frontera
last name: María del Carmen Almodóvar Pulido
role: Principal Investigator
affiliation: Hospital de Antequera
last name: Fernando Nebrera Navarro
role: Principal Investigator
affiliation: Hospital de Formentera
last name: Rosario Javier Martínez
role: Principal Investigator
affiliation: University Hospital Virgen de las Nieves
last name: Francisca Guerrero Sánchez
role: Principal Investigator
affiliation: Hospital Universitario Puerta del Mar
last name: Pilar Retamar Gentil
phone: 0034 955 04 04 50
email: gestionensayosclinicos.fps@juntadeandalucia.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Pneumonia