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ISRCTN
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ISRCTN17875607
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DOI
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10.1186/ISRCTN17875607
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Usefulness of a three-step guideline to reduce length of hospital stay for patients with community-acquired pneumonia: a randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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FIS 040139
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Study hypothesis
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The implementation of a three-step guideline would be effective and safe in reducing length of stay for hospitalized patients with community-acquired pneumonia
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approved by the Ethics Committee of the University of Bellvitge (Comite Etic d´Investigació de l´Hospital Universitari de Bellvitge), July 2004, reference number: 05/FIS-008
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Community-acquired pneumonia
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Participants - inclusion criteria
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Immunocompetent adults (aged >18 years) who have received a diagnosis of community-acquired pneumonia in the emergency department and are admitted to the hospital
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Participants - exclusion criteria
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1. Severe immunosuppression (neutropenia, transplantation, human immunodeficiency virus [HIV] infection)
2. Imminent death
3. Intensive care unit (ICU) admission
4. Shock
5. Complicated pleural effusion
6. Aspiration pneumonia
7. Social problem (homelessness)
8. Not able to drink and eat
9. Absence of written informed consent
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Anticipated start date
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24/04/2006
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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376
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Interventions
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Patients will be randomly assigned to one of two groups:
1. Use of a three-step guideline, including early mobilization, and pre-defined criteria for switch antibiotic therapy and hospital discharge
2. Control group (conventional management)
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Primary outcome measure(s)
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Length of hospital stay
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Secondary outcome measure(s)
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1. Time to switch
2. Readmission (<30 days)
3. Overall mortality (<30 days)
4. Satisfaction with care
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Sources of funding
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Investigation of Sanitary Funding (Fondo de Investivación Sanitaria) IDIBELL
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Trial website
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Publications
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1. 2012 abstract in http://www.ncbi.nlm.nih.gov/pubmed/22732747
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Contact name
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Dr
Jordi
Carratala
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Address
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Infectious Disease Service
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L´Hospitalet
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City/town
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Barcelona
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Zip/Postcode
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08907
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Country
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Spain
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Tel
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+34 (0)93 260 76 25
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Fax
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+34 (0)93 260 76 37
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Email
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jcarratala@wanadoo.es
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Sponsor
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Spanish National Health Service (Fondo de Investigación Sanitaria)
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Address
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Sinesio Delgado 4
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City/town
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Madrid
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Zip/Postcode
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28029
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Country
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Spain
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Date applied
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18/04/2006
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Last edited
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02/08/2012
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Date ISRCTN assigned
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17/05/2006
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