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Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals

Sponsor
Fundación Pública Andaluza Progreso y Salud (Other)
Overall Status
Unknown status
CT.gov ID
NCT02224716
Collaborator
(none)
968
Enrollment
1
Location
17
Duration (Months)
56.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    968 participants
    Observational Model:
    Cohort
    Official Title:
    Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals
    Study Start Date :
    Jul 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Pre-intervention All patients admitted with a diagnosis of CAP
    Post intervention All patient admitted with a diagnosis of CAP

    Outcome Measures

    Primary Outcome Measures

    1. Antimicrobial use in patients hospitalized for CAP. [twelve months]

      It is measured in defined daily doses (DDD) per 100 hospital stay of patients hospitalized with CAP.

    2. Mortality rate to 30 days [twelve months]

      Number of death of patients hospitalized with CAP, stratified by CURB-65 score.

    Secondary Outcome Measures

    1. CAP severity CURB-65 or PSI registered. [twelve months]

      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.

    2. Microbiological samples at admission. [twelve months]

      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.

    3. Appropriate supportive treatment [Twelve months]

      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.

    4. Empirical treatment [Twelve months]

      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.

    5. Appropriate sequential therapy. [Twelve months]

      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.

    6. Specific antimicrobial treatment [Twelve months]

      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

    7. Total duration of antibiotic therapy. [Twelve months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of CAP at hospital admission .

    • Age: 18 years or more.

    Exclusion Criteria:

    • Patients with nosocomial pneumonia or criteria related to health care.

    • Patients with severe immunosuppression (HIV infection with <200 CD4+ lymphocytes / mm3), neutropenia (<500 neutrophils / mm3).

    • Patient treated with immunosuppressive drugs.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundación Pública Progreso y Salud Sevilla Spain 41092

    Sponsors and Collaborators

    • Fundación Pública Andaluza Progreso y Salud

    Investigators

    • Study Director: Pilar Retamar Gentil, Hospital Universitario Virgen Macarena
    • Principal Investigator: Juan Enrique Corzo Delgado, Hospital Universitario Virgen de Valme
    • Principal Investigator: Cristina Roca Oporto, Hospitales Universitarios Virgen del Rocío
    • Principal Investigator: Montserrat Pérez Pérez, Hospital de la Línea de la Concepción
    • Principal Investigator: Salvador López Cardenas, Hospital de Jerez de la Frontera
    • Principal Investigator: María del Carmen Almodóvar Pulido, Hospital de Antequera
    • Principal Investigator: Fernando Nebrera Navarro, Hospital de Formentera
    • Principal Investigator: Rosario Javier Martínez, University Hospital Virgen de las Nieves
    • Principal Investigator: Francisca Guerrero Sánchez, Hospital Universitario Puerta del Mar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundación Pública Andaluza Progreso y Salud
    ClinicalTrials.gov Identifier:
    NCT02224716
    Other Study ID Numbers:
    • FIS-ANT-2014-01
    First Posted:
    Aug 25, 2014
    Last Update Posted:
    Jun 12, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Jun 12, 2015